Proposed Rule2024-06037
Banned Devices; Proposal To Ban Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior
Primary source
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Published
March 26, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is proposing to ban electrical stimulation devices (ESDs) intended for self-injurious behavior (SIB) or aggressive behavior (AB). FDA has determined these devices present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labeling. This proposal follows a court decision vacating a prior ban and amendment to the Federal Food, Drug, and Cosmetic Act clarifying our authority to ban a device for one or more intended uses. This action, if finalized, will mean ESDs for SIB and AB are adulterated and not legally marketed.
Full Text
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<title>Federal Register, Volume 89 Issue 59 (Tuesday, March 26, 2024)</title>
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[Federal Register Volume 89, Number 59 (Tuesday, March 26, 2024)]
[Proposed Rules]
[Pages 20882-20897]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-06037]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 882 and 895
[Docket No. FDA-2023-N-3902]
RIN 0910-AI84
Banned Devices; Proposal To Ban Electrical Stimulation Devices
for Self-Injurious or Aggressive Behavior
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
proposing to ban electrical stimulation devices (ESDs) intended for
self-injurious behavior (SIB) or aggressive behavior (AB). FDA has
determined these devices present an unreasonable and substantial risk
of illness or injury that cannot be corrected or eliminated by
labeling. This proposal follows a court decision vacating a prior ban
and amendment to the Federal Food, Drug, and Cosmetic Act clarifying
our authority to ban a device for one or more intended uses. This
action, if finalized, will mean ESDs for SIB and AB are adulterated and
not legally marketed.
DATES: Either electronic or written comments on the proposed rule must
be submitted by May 28, 2024.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of May 28, 2024. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2023-N-3902 for ``Banned Devices; Proposal to Ban Electrical
Stimulation Devices for Self-Injurious or Aggressive Behavior.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you
[[Page 20883]]
must identify this information as ``confidential.'' Any information
marked as ``confidential'' will not be disclosed except in accordance
with 21 CFR 10.20 and other applicable disclosure law. For more
information about FDA's posting of comments to public dockets, see 80
FR 56469, September 18, 2015, or access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents, the
plain language summary of the proposed rule of not more than 100 words
as required by the ``Providing Accountability Through Transparency
Act,'' or the electronic and written/paper comments received, go to
<a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in
brackets in the heading of this document, into the ``Search'' box and
follow the prompts and/or go to the Dockets Management Staff, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Rebecca Nipper, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1540, Silver Spring, MD 20993-0002, 301-796-6527,
<a href="/cdn-cgi/l/email-protection#0f5d6a6d6a6c6c6e2141667f7f6a7d4f696b6e2167677c21686079"><span class="__cf_email__" data-cfemail="386a5d5a5d5b5b5916765148485d4a785e5c591650504b165f574e">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Executive Summary
A. Purpose of the Proposed Rule
B. Summary of the Major Provisions of the Proposed Rule
C. Legal Authority
D. Costs and Benefits
II. Table of Abbreviations/Commonly Used Acronyms in This Document
III. Background
A. Introduction
B. Need for the Regulation
C. FDA's Current Regulatory Framework
D. History of the Rulemaking
IV. Legal Authority
V. Evaluation and Discussion of Data and Information
A. Risks of ESDs for SIB or AB
B. Effects of ESDs for SIB or AB
C. State of the Art for Treating SIB or AB
D. Labeling and Correcting or Eliminating Substantial and
Unreasonable Risks
VI. Description of the Proposed Rule
A. Applicability (Proposed Sec. 895.105)
B. Proposed Conforming Amendment (Sec. 882.5235)
VII. Proposed Effective and Compliance Dates
VIII. Preliminary Economic Analysis of Impacts
A. Introduction
B. Summary of Benefits, Costs, and Transfers
IX. Analysis of Environmental Impact
X. Paperwork Reduction Act of 1995
XI. Federalism
XII. Consultation and Coordination With Indian Tribal Governments
XIII. References
I. Executive Summary
A. Purpose of the Proposed Rule
FDA is proposing to ban ESDs intended for self-injurious behavior
(SIB) or aggressive behavior (AB) pursuant to the Agency's authority
under the Federal Food, Drug, and Cosmetic Act (FD&C Act) after
determining that the devices present an unreasonable and substantial
risk of illness or injury that cannot be corrected or eliminated by
labeling. FDA previously issued a final rule in 2020 banning these
devices (2020 Final Rule) (85 FR 13312, March 6, 2020), which was
vacated by the U.S. Court of Appeals for the District of Columbia
Circuit (D.C. Circuit) on July 6, 2021. The D.C. Circuit opined that
FDA's authority to ban devices intended for human use under the FD&C
Act, as it existed at the time, did not permit FDA to ban a device for
some (but not all) of its intended uses. Following the D.C. Circuit's
decision, Congress amended the FD&C Act to expressly state that FDA's
authority to ban a device includes the authority to ban some intended
uses of a device, even if the Agency does not seek to ban it for all
intended uses. The amendment to the FD&C Act thereby authorizes FDA to
issue a ban that applies to specific intended uses, such as the
previous ban on ESDs for self-injurious and aggressive behavior. This
proposed rule, if finalized, would reestablish the ban now that it is
clear that FDA has the authority to do so.
ESDs are aversive conditioning devices that apply a noxious
electrical stimulus (a shock) to a person's skin to condition behavior
to reduce or cease SIB and AB. SIB and AB frequently manifest in the
same individual, and people with intellectual or developmental
disabilities exhibit these behaviors at disproportionately high rates.
Notably, some people with intellectual or developmental disabilities
who exhibit SIB and AB have difficulty communicating and cannot make
their own treatment decisions because of such disabilities, meaning
they are part of a vulnerable population.
In issuing the 2020 Final Rule, FDA determined that the medical
literature shows that ESDs for SIB or AB pose a number of psychological
harms including depression, post-traumatic stress disorder (PTSD),
anxiety, fear, panic, substitution of other negative behaviors,
worsening of underlying symptoms, and learned helplessness (becoming
unable or unwilling to respond in any way to the ESD); and the devices
present the physical risks of pain, skin burns, and tissue damage. We
also found that other sources, such as experts in the field, State
agencies that regulate ESD use, and records from the only facility that
has recently manufactured and is currently using ESDs for SIB or AB,
indicate that ESDs pose additional risks such as suicidality, chronic
stress, acute stress disorder, neuropathy, withdrawal, nightmares,
flashbacks of panic and rage, hypervigilance, insensitivity to fatigue
or pain, changes in sleep patterns, loss of interest, difficulty
concentrating, and injuries from falling. We also determined that
state-of-the-art treatments for this patient population have evolved
away from ones that include ESD use and toward various positive
behavioral treatments, sometimes combined with pharmacological
treatments. Although the available data and information suggest that
some individuals subject to ESDs exhibit an immediate reduction or
cessation of the targeted behavior, the available evidence has not
established a durable long-term conditioning effect or an overall
favorable benefit-risk profile for ESDs for SIB and AB.
For this proposed rule, FDA has determined that there have been no
material changes regarding these topics in the available literature
that impact our findings and assessments in the 2020 Final Rule.
Accordingly, FDA has determined on the basis of all available data and
information that ESDs for SIB or AB present an unreasonable and
substantial risk of illness or injury and that such risk cannot be
corrected or eliminated by labeling or by a change in labeling. FDA is
issuing this proposed rule to give notice of FDA's determination and
give interested persons an opportunity to comment on the determination
and FDA's proposal to ban ESDs for SIB and AB. All references to
section numbers are references to section numbers in this proposed rule
unless otherwise specified.
B. Summary of the Major Provisions of the Proposed Rule
We are proposing to amend part 895 (21 CFR part 895) to designate
ESDs for SIB or AB as banned devices. If this proposed rule is
finalized as proposed, the ban would include only aversive conditioning
devices intended to apply a noxious electrical stimulus to a person's
skin to reduce or cease aggressive or self-injurious behavior. The
proposed ban would apply to devices already in commercial
[[Page 20884]]
distribution and devices already in use by the ultimate (end) user, as
well as devices to be sold or commercially distributed in the future. A
banned device is an adulterated device, subject to enforcement action.
Additionally, a device that is banned for one or more intended uses is
not legally marketed within the meaning of section 1006 of the FD&C Act
(21 U.S.C. 396) when intended for such use or uses. The ban would not,
however, prevent further study of such devices pursuant to an
investigational device exemption if the requirements for such an
exemption are met. We also are proposing conforming edits to 21 CFR
part 882 to clarify that ESDs are banned when used to reduce or cease
SIB or AB.
C. Legal Authority
We are proposing to issue this rule pursuant to FDA's authority to
ban devices intended for human use, as recently amended by Congress. We
also are proposing to issue this rule under the authority to issue
regulations for the efficient enforcement of the FD&C Act.
D. Costs and Benefits
This proposed rule, if finalized, would reestablish the ban of ESDs
for SIB or AB. FDA has determined that these devices present an
unreasonable and substantial risk of illness or injury that cannot be
corrected or eliminated by labeling or a change in labeling. The
proposed rule, if finalized, would apply to both new devices and
devices already in distribution and use. Unquantified benefits would
include reduction in physical and psychological adverse effects from
using ESDs on individuals, as well as benefits to society in terms of
protecting vulnerable populations. We quantify costs for the case in
which the affected individuals might move to another facility and costs
to the affected entities, who use the device on such individuals, to
read and understand the rule. We estimate that the annualized costs
over 10 years would range from $0.00 million to $9.17 million with a
primary estimate of $4.59 million at both a 7 percent and a 3 percent
discount rate.
II. Table of Abbreviations/Commonly Used Acronyms in This Document
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Abbreviation/ acronym What it means
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AB.................................. Aggressive Behavior.
ABA................................. Applied Behavior Analysis.
ABAI................................ Association for Behavior Analysis
International.
AE.................................. Adverse Event.
DBT................................. Dialectical Behavioral Therapy.
EA.................................. Environmental Assessment.
ESD................................. Electrical Stimulation Device.
FA.................................. Analogue Functional Analysis.
FDORA............................... Food and Drug Omnibus Reform Act
of 2022.
FONSI............................... Finding of No Significant Impact.
FD&C Act............................ Federal Food, Drug, and Cosmetic
Act.
GED................................. Graduated Electronic Decelerator.
mA.................................. Milliampere.
MSW................................. Municipal Solid Waste.
PBS................................. Positive Behavioral Support.
PTSD................................ Post-traumatic Stress Disorder.
SIB................................. Self-Injurious Behavior.
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III. Background
FDA is proposing to ban certain devices that apply a noxious
electrical stimulus to attempt to reduce or stop undesirable, injurious
behaviors frequently manifested by vulnerable people. Specifically,
this rulemaking would ban ESDs for SIB or AB because the devices
present an unreasonable and substantial risk of illness or injury that
cannot be corrected or eliminated by labeling or a change in labeling.
This is the second ban on these devices we are undertaking to protect
and promote the public health. As we will explain in more detail, the
U.S. Court of Appeals for the District of Columbia Circuit (D.C.
Circuit) vacated the first ban.
A. Introduction
ESDs for SIB or AB give people an often-painful electric shock to
try to make them stop behaving in ways that are harmful and/or
dangerous and that are often related to other underlying intellectual
or developmental disabilities. More specifically, ESDs are a type of
aversive conditioning device that apply a noxious electrical stimulus
(the shock) to a person's skin in an attempt to reduce or cease self-
injurious or aggressive behaviors. SIB commonly includes head-banging,
hand-biting, excessive scratching, and picking of the skin. However,
SIB can be more extreme and result in bleeding; broken, even protruding
bones; blindness from eye-gouging or poking; other permanent tissue
damage; or injuries from swallowing dangerous objects or substances. AB
can involve repeated physical assaults and can be a danger to the
individual, others, or property. In this proposed rule, like much of
the scientific literature, we discuss SIB and AB in tandem and use the
phrase ``SIB or AB'' to refer to SIB, AB, or both. A more detailed
discussion of SIB and AB and intellectual or developmental disabilities
as they relate to individuals with SIB or AB can be found in section
I.B of the previous proposed rule to ban these devices (2016 Proposed
Rule) (81 FR 24386 at 24389).
ESDs that are subject to this proposed ban are intended to reduce
SIB or AB according to the principle of aversive conditioning. Aversive
conditioning pairs a noxious stimulus (such as, here, a noxious
electric shock delivered to an individual's skin) with a target
behavior; the goal is that the individual eventually associates the
noxious stimulus with the behavior. Pairing a target behavior with
shocks from an ESD is intended to affect behavior in two ways: by
interrupting the target behavior as an immediate response to the
stimulus--for example, in response to pain--and, over time, through a
conditioned reduction in the target behavior if the person learns to
associate the shock with the target behavior (and can learn to control
the behavior). Associating the unwanted behavior with the shock is
intended to decrease the frequency of the behavior or stop it
altogether.
However, as explained here, ESDs pose a number of serious risks and
have not been shown to be effective, and modern treatments for SIB or
AB have been generally successful without involving the use of ESDs.
State-of-the-art treatments instead include conducting a functional
behavioral assessment to determine the causes and triggers of self-
injury or aggression, then using that information to design a plan with
supportive approaches, consisting of multiple elements, to modify the
behavior. In some cases, pharmacotherapy is an appropriate element of a
treatment plan, depending on the specific patient. These approaches
have generally been successful, even for some of the most difficult
cases. The use of ESDs was mostly abandoned decades ago, in part
because the shocks can be painful or very painful for the recipients.
Only one facility in the United States still applies these devices to
individuals.
Although in 2018 a Massachusetts court found, for the purpose of
considering whether to lift a consent decree, that there was no
professional consensus as to whether ESDs are part of standard of care
for treating individuals with intellectual and developmental
disabilities,\1\ the professional consensus regarding the accepted
standard of care and such use of ESDs is not an issue in this
rulemaking (see discussion in the 2020 Final Rule, 85 FR 13312 at 13314
through 13315). Rather, to ban a device
[[Page 20885]]
under section 516 of the FD&C Act (21 U.S.C. 360f), FDA must determine
the device presents an ``unreasonable and substantial risk of illness
or injury.'' In making this determination, FDA analyzes whether the
risks the device poses to individuals are important, material, or
significant in relation to its benefits to the public health, and FDA
compares those risks and benefits to the risks and benefits posed by
alternative treatments being used in current medical practice (which
relates to what FDA refers to as ``the state of the art'') (85 FR 13312
at 13315; 81 FR 24386 at 24388). The purpose of considering the
alternatives used in current medical practice to treat a particular
patient population is to assess and compare the risks and benefits of
those alternatives to the risks and benefits of the device that is the
subject of the ban, not to determine whether the device that is the
subject of the ban is part of the standard of care or state of the art.
For these reasons, as stated in the 2020 Final Rule, whether
punishment, contingent shock, or ESDs are within the standard of care
or state of the art is not an issue in this rulemaking (85 FR 13312 at
13341). In sum, the court's decision has no legal or scientific bearing
on this proposed ban.
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\1\ On September 7, 2023, the Supreme Judicial Court of
Massachusetts considered the narrow question of whether the probate
judge abused her discretion in making that finding based upon the
evidence before her at the time of that decision (all of which was
from 2016 and earlier), and concluded that she had not. See Judge
Rotenberg Educational Center, Inc. v. Commissioner of the Department
of Developmental Services, 492 Mass. 772 (September 7, 2023).
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B. Need for the Regulation
This rulemaking would protect and promote the public health by
banning ESDs for SIB or AB, which would prevent this patient population
from being subjected to a device that poses a substantial and
unreasonable risk of illness or injury. As we explained in the previous
rulemaking to ban ESDs for SIB and AB, people who manifest SIB or AB
often have intellectual and developmental disabilities including, but
not limited to, autism spectrum disorder, Down syndrome, or Tourette
syndrome, as well as other cognitive or psychiatric disorders and
severe intellectual impairment (including a broad range of intellectual
measures) (see, e.g., 81 FR 24386 at 24389). Notably, some people with
such intellectual and developmental disabilities may have difficulty
communicating and may not be able to make their own treatment decisions
because of such disabilities (see, e.g., 85 FR 13312 at 13329). This,
among other reasons, means that many people who exhibit SIB or AB
constitute a vulnerable population. For people who manifest SIB or AB,
ESDs intended for those conditions present a substantial and
unreasonable risk of illness or injury that cannot be corrected or
eliminated by labeling or a change in labeling. As such, a ban on these
devices for these intended uses is warranted.
As discussed in section IV below, section 516(a) of the FD&C Act
authorizes FDA to ban a device for one or more intended uses, by
regulation, if we find, on the basis of all available data and
information, that such a device presents substantial deception or an
unreasonable and substantial risk of illness or injury. Accordingly,
based on the serious risks posed by ESDs for SIB or AB, the inadequacy
of data to support their effectiveness, and the positive benefit-risk
profiles of the state-of-the-art alternatives for the treatment of SIB
or AB, FDA has determined that ESDs present an unreasonable and
substantial risk of illness or injury that cannot be corrected or
eliminated by labeling. The proposed rule would apply to devices
already in distribution and use, as well as to future sale and
distribution of these devices. The purpose of this notice is to seek
comments on FDA's proposal to ban ESDs used for SIB or AB and comments
on any other associated issues. Section V of this document discusses
the information and data that support these proposed findings.
C. FDA's Current Regulatory Framework
The FD&C Act, as amended by the Medical Device Amendments of 1976
(1976 Amendments) (Pub. L. 94-295), establishes a comprehensive system
for the regulation of medical devices intended for human use. Section
513 of the FD&C Act establishes three categories (classes) of devices,
reflecting the regulatory controls needed to provide reasonable
assurance of their safety and effectiveness: class I (general
controls), class II (special controls), and class III (premarket
approval) (see 21 U.S.C. 360c).
In 1979, FDA classified aversive conditioning devices as class II
(see Sec. 882.5235 (21 CFR 882.5235)), which was consistent with the
recommendation of the Neurological Device Classification Panel in 1978.
Class II devices are those devices for which general controls by
themselves are insufficient to provide reasonable assurance of safety
and effectiveness, but for which there is sufficient information to
establish special controls to provide such assurance, including the
promulgation of performance standards, postmarket surveillance, patient
registries, development and dissemination of guidelines,
recommendations, and other appropriate actions the Agency deems
necessary to provide such assurance (section 513(a)(1)(B) of the FD&C
Act).
Aversive conditioning devices, as a device type, administer an
electric shock or another noxious stimulus to a patient to modify
undesirable behavioral characteristics (see Sec. 882.5235). Thus, ESDs
intended for SIB and AB, which administer shocks to modify target
behaviors, are within the aversive conditioning device classification
regulation. As discussed in more detail in section I.D. of the previous
proposed rule (81 FR 24386 at 24391), in the late 1970s, FDA and the
panelists of the Neurological Device Classification Panel believed that
performance standards could adequately assure the safety and
effectiveness of aversives and proposed a classification accordingly.
We received no comments from the public on the proposed rule, and we
issued the final rule classifying aversives as proposed at Sec.
882.5235 (44 FR 51726 at 51765, September 4, 1979).
As we explained during the previous rulemaking to ban ESDs for SIB
and AB, and as remains true, FDA now has a better understanding of the
risks and benefits presented by these devices than we did 44 years ago
when these devices were classified. As summarized in section III.B and
explained more fully in section V.E. of the 2020 Final Rule, the state
of the art for the treatment of SIB and AB has progressed significantly
over that time period (85 FR 13312 at 13337 through 13344). The
development of the scientific literature and treatments for these
conditions only underscores that the risk of illness or injury from the
use of ESDs for SIB and AB is unreasonable and substantial.
D. History of the Rulemaking
FDA previously banned ESDs for SIB and AB in a final rule issued on
March 6, 2020, pursuant to the Agency's authority under section 516 of
the FD&C Act (85 FR 13312 at 13354). Specifically, section 516 of the
FD&C Act provides that FDA may ban a device intended for human use if
the Agency determines that the device presents substantial deception or
an unreasonable and substantial risk of illness or injury that cannot
be corrected or eliminated by labeling or change in labeling. Leading
up to the final ban, FDA held a public meeting of the Neurological
Devices Panel of the Medical Devices Advisory Committee on April 24,
2014 (see 79 FR 17155, March 27, 2014) (Ref. 1), issued a proposed ban
in the Federal Register of April 25, 2016, and considered comments on
the proposal from interested stakeholders (81 FR 24386). These
activities garnered significant interest, and FDA received and reviewed
voluminous information to develop the final rule banning ESDs for SIB
and AB.
[[Page 20886]]
FDA issued the 2020 ban because we determined, based on all
available information and data at that time, that ESDs for SIB or AB
present an unreasonable and substantial risk of illness or injury that
cannot be corrected or eliminated by labeling or a change in labeling.
FDA found the weight of the evidence indicates that ESDs for SIB or AB
present a number of psychological and physical risks. We determined the
evidence does not establish that ESDs improve the underlying causative
disorder or effectively condition individuals to achieve durable
reduction of SIB or AB for a clinically meaningful period of time. FDA
also found the weight of the evidence indicates that the state-of-the-
art treatment for individuals with SIB or AB relies on multielement
positive interventions, for example, paradigms such as positive
behavior support (PBS) or dialectical behavioral therapy (DBT),
sometimes in conjunction with pharmacological treatments (85 FR 13312
at 13315 and 13337). Even in cases in which behavioral modification
plans include punishment techniques, the techniques are significantly
less intrusive than ESDs and do not inflict pain; for example, they
include timeouts.
Following the publication of the 2020 ban, the sole manufacturer
and only facility to use ESDs for SIB and AB, The Judge Rotenberg
Educational Center, Inc. (JRC), challenged in court FDA's authority to
issue the 2020 ban. On July 6, 2021, the D.C. Circuit vacated the 2020
ban. See Judge Rotenberg Educational Center, Inc. v. FDA, 3 F.4th 390
(D.C. Cir. 2021). The court interpreted section 516 of the FD&C Act, as
it existed at the time, and section 1006 of the FD&C Act, as not
permitting FDA to ban devices for specific intended uses, in that
instance ESDs for SIB or AB, without banning the device for all
intended uses.
Following the court's decision, Congress enacted the Food and Drug
Omnibus Reform Act of 2022 (FDORA) (Pub. L. 117-328). FDORA amended
section 516(a) of the FD&C Act to expressly state that FDA's authority
to ban a device intended for human use includes the authority to ban a
device for one or more intended uses, and that a device banned for one
or more intended uses is not a legally marketed device under section
1006 of the FD&C Act. As amended, the statute is clear that FDA may
issue a ban such as the previous ban on ESDs for SIB or AB, which
applies to one or more specific intended uses. After reviewing
publications and other information that have become known to the Agency
in the brief interim between the issuance of the previous ban in 2020
and now, and determining that it does not change our conclusion that
ESDs for SIB or AB present an unreasonable and substantial risk of
illness or injury that cannot be corrected or eliminated by labeling or
a change in labeling, FDA is proposing to ban ESDs intended for SIB or
AB under section 516 of the FD&C Act, as amended.
IV. Legal Authority
Under section 516 of the FD&C Act, FDA may ban a device by
regulation if we find, on the basis of all available data and
information, that such a device with the relevant intended use(s)
presents substantial deception or an unreasonable and substantial risk
of illness or injury that cannot be corrected or eliminated by labeling
or change in labeling (see 21 U.S.C. 360f(a)(1) and (2), as amended by
section 3306 of FDORA).
Section 3306 of FDORA expressly provides that FDA has the authority
to ban a device for one or more intended uses and that FDA's authority
under section 516 of the FD&C Act is not limited only to bans of a
device for all of its intended uses. The legislative history reinforces
that section 516 of the FD&C Act, as amended, authorizes FDA to ban a
device regardless of whether or not the ban includes other devices that
are technologically similar but have different intended uses (see H.
Rept. 117-348 at 65). The regulatory status of a device has long
depended on its intended use(s), even before the enactment of the 1976
Amendments (see id.). A product's status as a device regulated by FDA,
along with its classification, premarket pathway, labeling, and other
requirements all ``very much depend on its intended use'' (id. at 65-
66). The amendment to section 516 of the FD&C Act makes clear that the
same principle applies to FDA's banning authority, permitting FDA to
ban certain intended use(s) of a type of technology that meet the
standard to ban devices, while not banning others that do not (see id.
at 66).
A banned device, as defined in part by its intended use(s), is
adulterated under section 501(g) of the FD&C Act (21 U.S.C. 351(g)),
except to the extent it is being studied pursuant to an investigational
device exemption under section 520(g) of the FD&C Act (21 U.S.C.
360j(g)). The FD&C Act defines various prohibited acts respecting
adulterated devices (see 21 U.S.C. 331).
This proposed rule is also issued under section 701(a) of the FD&C
Act, which provides FDA authority to issue regulations for the
efficient enforcement of the FD&C Act (see 21 U.S.C. 371(a)). This
rule, if finalized, would enable FDA to efficiently enforce the FD&C
Act.
Part 895 sets forth the regulations that apply to banning devices
under section 516 of the FD&C Act. Consistent with those regulations
(and other applicable legal provisions), we are proposing findings,
based on all available information and data, that ESDs for SIB or AB
present a substantial and unreasonable risk of illness or injury.
In determining whether a risk of illness or injury is
``substantial,'' FDA considers whether the risk posed by the continued
marketing of the device, or continued marketing of the device as
presently labeled, is important, material, or significant in relation
to the benefit to the public health from its continued marketing (see
Sec. 895.21(a)(1) (21 CFR 895.21(a)(1))).
Although FDA's device banning regulations do not define
``unreasonable risk,'' we explained in the preamble to the final rule
establishing part 895 that, with respect to ``unreasonable risk,'' we
will conduct a careful analysis of risks associated with the use of the
device relative to the state of the art and the potential hazard to
patients and users (44 FR 29214 at 29215, May 18, 1979). The state of
the art with respect to this rule is the state of current technical and
scientific knowledge and medical practice with regard to the treatment
of patients exhibiting self-injurious and aggressive behavior.
Thus, in determining whether a device presents an ``unreasonable
and substantial risk of illness or injury'' for one or more intended
uses, FDA analyzes the risks and the benefits the device poses to
individuals when used for such intended use or uses, comparing those
risks and benefits to the risks and benefits posed by alternative
treatments being used in current medical practice. Actual proof of
illness or injury is not required; FDA need only find that a device
presents the requisite degree of risk on the basis of all available
data and information (H. Rept. 94-853 at 19; 44 FR 29214 at 29215).
If FDA determines that the risk can be corrected through labeling,
FDA will notify the responsible person of the required labeling or
change in labeling necessary to eliminate or correct such risk (see 21
CFR 895.25). Because FDA is proposing to determine that the risk
associated with using ESDs for SIB or AB cannot be corrected or
eliminated by labeling, we are not at this time notifying responsible
persons regarding labeling. If FDA finalizes this ban as proposed, ESDs
intended for SIB or AB
[[Page 20887]]
will be adulterated and not legally marketed within the meaning of
section 1006 of the FD&C Act when intended for SIB or AB.
To ban a device intended for human use, Sec. 895.21(d) requires
that a proposed ban briefly summarize:
<bullet> the Agency's findings regarding substantial deception or
an unreasonable and substantial risk of illness or injury;
<bullet> the reasons why FDA initiated the proceeding;
<bullet> the evaluation of the data and information FDA obtained
under provisions (other than section 516) of the FD&C Act, as well as
information submitted by the device manufacturer, distributer, or
importer, or any other interested party;
<bullet> the consultation with the classification panel;
<bullet> the determination that labeling, or a change in labeling,
cannot correct or eliminate the deception or risk;
<bullet> the determination of whether, and the reasons why, the ban
should apply to devices already in commercial distribution, sold to
ultimate users, or both; and
<bullet> any other data and information that FDA believes are
pertinent to the proceeding.
The previous proposed and final ban on ESDs for SIB or AB describe
this information extensively, and we do not repeat that information in
full here. Instead, because the primary change in circumstances leading
to this rulemaking is of a legal (not scientific) nature, this proposed
rule references the information and findings from the previous
rulemaking and briefly summarizes that information with reference to
the previous proposed rule, final rule, or both, as applicable. In
addition, this proposed rule discusses the new data and information
that FDA has become aware of since the 2020 Final Rule.
FDA notes that, although a banned device or banned intended use of
a device is not barred from clinical study under an investigational
device exemption pursuant to section 520(g) of the FD&C Act, any such
study must meet all applicable requirements. These include, but are not
limited to, requirements for: protection of human subjects (21 CFR part
50), financial disclosure by clinical investigators (21 CFR part 54),
approval by institutional review boards (21 CFR part 56), and
investigational device exemptions (21 CFR part 812).
V. Evaluation and Discussion of Data and Information
FDA has determined, on the basis of all available data and
information, that ESDs for SIB or AB present a substantial and
unreasonable risk of illness or injury. Given the relatively short
amount of time since the previous ban that we finalized in 2020, there
is very little relevant data or information that we have not already
considered and discussed in the previous rulemaking. The few
publications and other information that have become known to the Agency
in the brief interim between the issuance of the previous ban in 2020
and now do not change our conclusions regarding the risks or effects of
ESDs for SIB or AB or the state of the art of treatment for this
patient population. We are therefore referencing our previous
discussion and findings (81 FR 24386 at 24386 through 24412 and 85 FR
13312 at 13312 through 13349) in this rulemaking and supplementing them
with an explanation of how since-developed data and information have
added to our understanding of the relevant issues. We also are
associating with this rulemaking the public dockets created for the
previous rulemaking (Docket No. FDA-2016-N-1111) and the Neurological
Devices Panel of the Medical Devices Advisory Committee on April 24,
2014 (Docket No. FDA-2014-N-0238) and consider them part of this
proposed rule. All of the documents associated with Docket No. FDA-
2016-N-1111 and Docket No. FDA-2014-N-0238 are contained in the docket
for this proposed rule as well. With regard to the available data and
information, this proposed rule therefore focuses on new information
and data that we have become aware of since we issued the previous ban.
To identify and assess information that we had not previously
considered, we conducted a search for literature on the risks and
effects of ESDs for SIB or AB published since our systematic literature
review for the 2016 Proposed Rule and again assessed the state of the
art for treating SIB or AB.
Our search returned the following new sources: (1) 5 research
studies (3 case reports, an open label add-on study, and a
retrospective chart review); (2) 4 policy or consensus statements; a
task force report; (3) 11 commentaries by researchers, academics, or
practitioners; (4) a set of practice guidelines; (5) a followup survey
of 88 former patients of JRC that did and did not have ESDs as part of
their treatment plans; (6) and a meta-analysis. FDA weighed the new
information according to the same factors that we explained in the 2016
Proposed Rule and 2020 Final Rule.
During the development of the 2020 Final Rule, in the form of
comments to the docket, JRC provided the Agency with several JRC
studies, information, and numerous records of patients with SIB or AB
whose treatment plans include ESD use. Of the five new research
studies, four are authored or coauthored by JRC staff. The four JRC
research studies appear to be based largely on this same information
and patient data and, as discussed in sections V.A and B, have many of
the same significant limitations identified by FDA as the previously
submitted studies, meaning the studies are less likely to support
confidence in generalizable results than studies with more
scientifically sound designs and methodologies. As a result, while the
publication process adds some reassurances to the credibility of the
information and data, presenting previously submitted data in a
different form does little to add to overall knowledge about the risks
and effects of ESDs for SIB or AB.
Generally speaking, little new information or data have developed
since our previous consideration of banning ESDs for SIB or AB.
Nonetheless, the new material is consistent with the evidence FDA
previously considered regarding the risks presented by this device, the
lack of evidence of its effectiveness for the treatment of SIB or AB,
and the state of the art for treating SIB or AB, which includes
successful interventions that are less restrictive and lower risk, as
has been the case for decades (85 FR 13312 at 13341). Accordingly, we
have again found that the devices present a substantial and
unreasonable risk of illness or injury that cannot be corrected or
eliminated by labeling or change in labeling.
A. Risks of ESDs for SIB or AB
The new studies and other materials that FDA reviewed are
consistent with our previous findings regarding the risks of ESDs for
SIB or AB, including likely underreporting of adverse events (AEs). As
explained in the 2016 Proposed Rule and 2020 Final Rule, the risks
presented by ESDs are both psychological (including suffering) and
physical (including pain), each having a complex relationship with the
electrical parameters of the shock. The subjective experience of the
person receiving the shock can therefore be difficult to predict.
Physical reactions roughly correlate with the peak current of the shock
delivered by the ESD. However, various other factors such as sweat,
[[Page 20888]]
electrode placement, recent history of shocks, and body chemistry can
physically affect the sensation. As a result, the intensity or pain
experienced by an individual from a particular set of shock parameters
can vary greatly from patient to patient and from shock to shock. More
information about the relationship between the electrical parameters of
the shock and conditions that may affect patient perception can be
found in section I.C. of the 2016 Proposed Rule (81 FR 24386 at 24390
through 24391) and Response 14 of the 2020 Final Rule (85 FR 13312 at
13322).
Possible adverse psychological reactions are even more loosely
correlated with shock strength or intensity (85 FR 13312 at 13322). To
cause such adverse reactions, the shock needs to be subjectively
stressful enough to cause trauma or suffering, which does not
necessarily require a strong shock. Trauma becomes more likely, for
example, when the recipient does not have control over the shock or has
developed a fear of future shocks, neither of which is an electrical
parameter of the shock. A more detailed explanation of these phenomena
can be found in the 2016 Proposed Rule (81 FR 24386 at 24387) and the
2020 Final Rule (85 FR 13312 at 13324 through 13325).
To summarize, FDA found that the medical literature shows ESDs
present a number of psychological harms including depression, PTSD,
anxiety, fear, panic, substitution of other negative behaviors,
worsening of underlying symptoms, and learned helplessness (becoming
unable or unwilling to respond in any way to the ESD); and the devices
present the physical risks of pain, skin burns, and tissue damage.
FDA also considered risks identified through other sources, such as
experts in the field, State agencies that regulate ESD use, and records
from the only facility that has recently manufactured and is currently
using ESDs for SIB or AB. These sources further support the reports of
risks in the literature and indicate that ESDs pose additional risks
such as suicidality, chronic stress, acute stress disorder, neuropathy,
withdrawal, nightmares, flashbacks of panic and rage, hypervigilance,
insensitivity to fatigue or pain, changes in sleep patterns, loss of
interest, difficulty concentrating, and injuries from falling (85 FR
13312 at 13315). For more information about FDA's analysis regarding
the risks of ESDs for SIB and AB, see section V.C. of the 2020 Final
Rule (85 FR 13312 at 13321 through 13332).
We also concluded that the medical literature likely underreports
AEs. This is attributable to several factors including the small number
of subjects in the studies, many of whom have impaired ability to
demonstrate and communicate AEs; potential attribution by clinicians of
adverse effects to the patients' cognitive, intellectual, or
psychiatric conditions rather than to the device; methodological
limitations such as study design and the lack of a prespecified
systematic plan for monitoring AEs; and researcher bias (81 FR 24386 at
24395 through 24396; 85 FR 13312 at 13329 and 13331).
The new sources that are based largely on data and information that
FDA previously reviewed when developing the 2020 Final Rule support our
previous determinations for the 2020 Final Rule about the types of
risks posed by ESDs for SIB or AB. As a result, these new sources do
not significantly affect our previous assessment of risks.
Specifically, one meta-analysis of 150 reports and studies (Ref. 2) and
four commentaries (Refs. 3 to 6), including one by a JRC staff member,
report AEs associated with ESDs for SIB or AB. These sources identify
the following physical and psychological risks:
<bullet> pain (Refs. 2, 3, 5);
<bullet> escape or avoidance responses (Refs. 3 and 5);
<bullet> extreme anxiety manifesting as screaming, crying, negative
vocalizations when ESD was implemented, and attack (Refs. 3 and 5);
<bullet> tensing of the body (Ref. 3);
<bullet> emotional behavior (Ref. 3);
<bullet> fear (Refs. 4 to 6);
<bullet> feeling terrorized (Ref. 6);
<bullet> panic (Ref. 5);
<bullet> ``freezing'' (Ref. 5);
<bullet> attempts to remove the device (Ref. 5);
<bullet> distress (Refs. 2 and 4);
<bullet> burns (Refs. 3 and 6);
<bullet> tremor in the thigh during activation (Ref. 3); and
<bullet> temporary skin discoloration (Ref. 3).
In addition, the new sources based primarily on data and
information that FDA had not previously reviewed for the 2020 Final
Rule generally support these risks. A task force of the Association for
Behavior Analysis International (ABAI) reports pain and attempts to
remove the device (Ref. 7) and two of the studies (Refs. 8 and 9)
report pain, escape/avoidance, and/or temporary anxiety, as noted
below. While some of these new sources suggest that there is no strong
evidence of negative ``side effects'' of ESDs based on research to date
(Ref. 7) or no occurrence of AEs (Ref. 8), these conclusions are based
on studies that have significant limitations, as discussed below and in
the previous rulemaking (81 FR 24386 at 24400 through 24401). During
the previous rulemaking, some experts expressed concern about a
heightened risk of AEs ``from exposing a member of a vulnerable patient
population to continual, painful shocks over a period of years, in many
cases several years'' (85 FR 13312 at 13327).
As discussed in section V.B., the new studies continue to
demonstrate use of ESDs for lengthy, indefinite periods of time and
adaptation of some patients to the shocks (they no longer respond to
shocks), even at the strongest level. The use of ESDs for long periods
and on patients who have adapted to shocks would provide greater
opportunity for AEs to occur, or for existing AEs to get worse due to
cumulative effects, in a population largely consisting of vulnerable
individuals. A treatment plan that includes use of ESDs for individuals
with SIB or AB indefinitely (Ref. 10) would further heighten the
concern about the risks of AEs. As explained further in section V.B., a
173-patient retrospective chart review study suggests that JRC attempts
``planned fading'' of ESD use, defined in that study as the removal of
all ESD devices for any period, for only a relatively few number of
individuals the attending clinician believes are likely to succeed
(Ref. 9).\2\ Thus, most of the individuals would continue to accumulate
exposure to the risks of ESDs for SIB or AB. Further, a decision to use
ESDs for ``long-term management'' of SIB or AB (Ref. 10) could suppress
behavior in a manner that masks an underlying medical condition (Ref.
7). This in turn can affect access to (or the desire to access)
effective treatments, which itself represents a risk to health.
---------------------------------------------------------------------------
\2\ According to the study, only 23 of 173 individuals were in
the planned fading group.
---------------------------------------------------------------------------
The new sources also add evidence for the likelihood of
underreporting of AEs for the same reasons we previously found for the
medical literature reviewed for the 2020 ban: the impaired ability of
many subjects to demonstrate and communicate AEs, which also increases
the risk of harm to these individuals; difficulty of practitioners to
recognize feedback from patients indicating that an AE occurred;
methodological limitations in the studies; and researcher bias. Thus,
while some new sources indicate that research ``does not provide strong
evidence that [ESDs are] associated with negative side effects'' and
that the ``few studies presenting data on the side effects of [ESDs]
have reported only
[[Page 20889]]
positive collateral changes in responding,'' (Ref. 7), these
conclusions need to be viewed with these limitations in mind.
Like the medical literature considered for the 2020 Final Rule,
most of the new studies involve a small number of patients, some of
whom likely would have difficulty communicating or otherwise
demonstrating AEs, including injuries, due to cognitive, intellectual,
or psychiatric conditions. As noted in the 2016 Proposed Rule (81 FR
24386 at 24395), this difficulty may prevent providers from recognizing
feedback from patients indicating that an AE has occurred.
None of the new studies prospectively planned for the systematic
observation and collection of data regarding AEs, and very few AEs are
reported. Only one new study on the use of the GED, the only ESD still
in use for SIB or AB, identified any AEs (Ref. 9). That study, a
retrospective chart review of 173 patients authored by JRC staff,
reports only what the authors ``anecdotally'' found were ``the most
common side effects'': escape/avoidance responses and temporary anxiety
during the period between occurrence of the behavior and the
``programmed consequence,'' i.e., shock (Ref. 9). The study reports
that staff members who administered shocks were ``prompted to report
any adverse conditions,'' and acknowledges that ``a standardized a
priori system was not employed'' for monitoring AEs (Ref. 9). Thus, the
study does not report systematic, recorded counts of adverse events
based on specific identification or followup protocols. Rather, it
reports the authors' subjective opinion in hindsight. Three of the
other new studies, two of which were authored or coauthored by JRC
staff, include no assessment of AEs (Refs. 10 to 12).
The remaining new study, a case report coauthored by JRC staff,
reports ``no evidence of physical or psychological adverse effects when
GED is administered per protocol'' (Ref. 8). Despite that statement,
the study lists temporary pain as a ``con'' of GED use. Further, the
JRC coauthor of the study, who is also coauthor of three of the other
new studies, continues to acknowledge that ``[t]he obvious effect of
[the ESD] is pain caused when electrical current stimulates nociceptors
and sensory receptors'' (Ref. 3). As explained in the 2016 Proposed
Rule and 2020 Final Rule, FDA considers pain to be an AE. Such biases
against recognizing and/or recording certain harms as AEs creates doubt
that the studies adequately considered AEs and, therefore, the risks of
the device. Such biases also would impair an accurate benefit-risk
assessment; undesirable effects should not be presumed unavoidable,
much less go unaccounted for, even if they ultimately prove to be
reasonable. The pain ESDs cause is relevant because, although ESDs are
intended to apply an aversive stimulus, the pain they cause to attempt
to develop the aversion is nevertheless harmful.
All of the new studies are retrospective reviews of clinical
experience, not prospective studies. While retrospective reviews can be
informative, creating a plan to identify AEs in a standardized,
forward-looking way and ensure a comprehensive record from the outset
will generally provide much stronger support for a conclusion that a
lack of reported AEs means a lack of AEs to report.
As with the earlier studies, researcher bias and author conflicts
of interest also may have contributed to underreporting of AEs. As
indicated in section III.D., JRC is the sole manufacturer and only
facility to use ESDs for SIB or AB. Four of the five new studies that
looked at ESDs for SIB or AB were authored or coauthored by current JRC
staff and may have minimized AEs. As noted earlier, only one study
reports any AEs experienced by patients and limits reporting only to
the ``most common side effects,'' of which pain was not included (Ref.
9).
The other new sources that FDA reviewed also suggest a lack of
attention to the careful and systematic assessment of AEs in research
involving ESDs, and more generally, in research involving
intellectually and developmentally disabled individuals (Refs. 2, 4 to
6, 8, and 13 to 17). For instance, one meta-analysis looking at
reporting of AEs in research involving young autistic children notes
that ``[s]tudies of effectiveness did not systematically define,
monitor, or measure adverse events; instead they were reported in an ad
hoc fashion and considered tangential to the studies'' (Ref. 2).
Another author discussing research involving autistic individuals
opines that the inadequate attention to and examination of harms
amounts to ``negligent reporting'' (Ref. 13). While not all individuals
with SIB or AB are autistic, this information informs our general
understanding of the limitations in research involving individuals with
intellectual and developmental disabilities. This information tends to
show that research that, in general, involves people who have
difficulties communicating and, more specifically, involves the use of
ESDs for SIB or AB, often does not provide a complete picture of AEs.
Given the foregoing, FDA has not changed its determination that AEs
very likely have been underreported in the literature. More information
about FDA's prior conclusion that AEs likely are underreported in the
literature can be found in the 2020 Final Rule at Responses to Comments
26-29 of (85 FR 13312 at 13329 through 13332).
Thus, based on the totality of the information available to FDA,
our determination regarding the risks posed by ESDs for SIB or AB
identified in the 2020 Final Rule has not changed.
B. Effects of ESDs for SIB or AB
The new information that FDA reviewed does not change our previous
determinations regarding effectiveness of ESDs for SIB or AB. For the
2020 Final Rule, FDA determined that some individuals subject to ESDs
may exhibit an immediate interruption of the targeted behavior if the
shock is applied while the behavior is occurring, assuming the
individual has not adapted to the shocks (85 FR 13312 at 13333).
However, we also determined that the available evidence does not
establish that ESDs improve the underlying causative disorder or
condition an individual to achieve a durable reduction of SIB or AB for
a clinically meaningful period of time (85 FR 13312 at 13333). A
durable effect is one where an individual develops a conditioned
response, so the target behavior, along with the frequency of shocks,
is significantly reduced over a clinically meaningful period of time,
either while the individual continues to wear the ESD or after the ESD
is removed.
As we discussed in the 2020 Final Rule (see 85 FR 13312 at 13332),
FDA found some information in the scientific literature to suggest ESDs
may reduce SIB and AB in some individuals. However, as we explained,
the evidence cannot be generalized and is insufficient to demonstrate
effectiveness because the studies suffer from serious limitations that
limit confidence in the results, including weak design, small size,
confounding factors, outdated standards for conduct, and study-specific
methodological limitations. As discussed in the 2016 Proposed Rule,
generally a study's strength or weakness is related to design in a
number of ways, particularly through randomization, control, and the
number of study subjects. There have been no large, randomized, and
controlled trials, or even any large or randomized trials, of
[[Page 20890]]
ESDs for SIB or AB.\3\ Although there have been some studies with some
level of controls, the controls have been inadequate for effectiveness
to be demonstrated and they suffer from other significant limitations.
For further discussion about the strengths and weaknesses of study
designs and the limitations in the literature previously reviewed by
FDA, see section II.B.2 of the 2016 Proposed Rule (81 FR 24386 at 24400
through 24401) and responses to Comment 33 of the 2020 Final Rule (85
FR 13312 at 13332 through 13333).
---------------------------------------------------------------------------
\3\ A randomized controlled trial is prospective; the researcher
creates different conditions across groups at the outset and will
observe outcomes in the future. The researcher will eventually
compare the outcomes across groups, with the control group providing
confidence that the researcher-set conditions were responsible for
any differences.
---------------------------------------------------------------------------
For instance, as discussed in the previous rulemaking, one study
used a prospective case-control design. In addition to not being
randomized, the study also suffers from significant methodological
limitations. The study was not blinded, the sample size was extremely
small, and an unvalidated surrogate endpoint (decrease in mechanical
restraint rather than a direct measure of SIB) was used as the primary
outcome measure (81 FR 24386 at 24400; 85 FR 13312 at 13333). The study
also did not systematically assess AEs (85 FR 13312 at 13329).
FDA also reviewed a retrospective chart review during the previous
rulemaking. Retrospective reviews are often considered a relatively
weaker design because they do not include a control group. The study
also suffers from various methodological limitations that affected the
weight of the evidence (see 81 FR 24386 at 24401). The bulk of the
scientific articles reviewed during the prior rulemaking suggesting
effectiveness of ESDs for SIB and AB were case reports or series. Case
reports or series are even weaker than retrospective chart reviews
because they report on, and attempt to explain, the experiences of very
few, or even single, individuals (81 FR 24386 at 24400). Further,
designs that take an outcome as given and then work backwards in an
attempt to explain it are more vulnerable to bias than prospective
designs.
As explained in the 2016 Proposed Rule, conclusions drawn from
study designs that are not randomized or controlled are generally
considered weaker because they do not rule out other causes for any
differences in results, including selection bias, as effectively as
other study designs. Many factors contribute to the manifestation or
reduction of target behaviors and therefore can be significantly
confounding (81 FR 24386 at 24400). It is difficult to draw conclusions
regarding the effectiveness of ESDs from a study that does not control
for such confounding factors. Studies that do not plan for the
systematic observation and collection of data about AEs also may
overemphasize benefits, unduly implying greater safety and
reasonableness of the risks because such a study would not fully
account for the risks. Such studies will yield weaker conclusions with
respect to the benefit-risk profile. As noted in the 2016 Proposed
Rule, in the case of ESDs used for SIB or AB, randomization, control,
large numbers of subjects, and AE reporting are critical to
understanding the benefit-risk profile (81 FR 24386 at 24400).
The Agency also has had concerns regarding the fact that some of
the authors of such studies and a member of one publication's editorial
board were affiliated with JRC, which suggests potential researcher
bias and conflicts of interest (81 FR 24386 at 24401). For more
information on the limitations identified by FDA in the medical
literature FDA considered for the 2020 Final Rule, see the 2016
Proposed Rule (81 FR 24386 at 24400 and 24401) and Responses 31 and 33
in the 2020 Final Rule (85 FR 13312 at 13332 and 13333).
As explained in the 2020 Final Rule, the ability to achieve durable
effects by aversively conditioning behavior is critical to the
evaluation of the effectiveness of ESDs for SIB or AB (see 85 FR 13312
at 13333). In its comments in the previous rulemaking, JRC relied on
its fading of some individuals off ESDs to support its arguments
regarding the device's ability to condition an individual to achieve a
durable reduction in SIB and AB. The gradual reduction in the use of
the device is part of ``fading,'' which would presumably be implemented
once the individual has associated the target behaviors with the
noxious stimulus. However, both the previously reviewed and new
evidence indicate that only a small percentage of individuals at JRC
(the only facility that applies the devices for SIB or AB) have been
completely faded off the ESD--and that the device has been used on some
individuals for years and even decades (see 85 FR 13312 at 13335 and
13336; Refs. 7 to 9). While one study suggests that there also are a
number of patients who have tolerated some degree of fading with
continued availability of the ESD (estimated at 20 percent ranging from
hours to months) (Ref. 8), the study acknowledges that the percentage
is only an estimate and suffers from a number of the limitations
discussed above.
Among the new studies, the 173-patient retrospective review
indicates that JRC views fading, defined in that study as the removal
of all ESD devices for any period, as likely to succeed in only a small
number of individuals. JRC selects for ``planned fading'' only a small
percentage of individuals whom JRC assesses to have likely demonstrated
low rates of problem behaviors over extended periods of time, higher
rates of alternative behaviors, and the acquisition of new skills (23
of 173 patients in the study) (Ref. 9). Also, as has been observed in
the literature, once the ESD is removed, SIB and AB can exceed pre-
baseline levels (85 FR 13312 at 13335). This evidence undermines the
claim that ESDs are effective for durable behavior conditioning for SIB
or AB. Further, JRC provided no information regarding clinical
protocols, treatment plans, or behavior frequencies for individuals
after they stopped use and left JRC. As explained in the 2020 Final
Rule, such data are important in order to understand, for example,
whether behaviors worsened or improved after discontinuation of ESD use
and whether ESDs or other, non-aversive, treatments are responsible for
any successes (85 FR 13312 at 13336).
In the previous rulemaking, FDA also discussed evidence indicating
that some individuals can experience adaptation to ESD shocks after
being shocked for some period of time. This means that, to the extent a
patient may have been responding to ESD shocks, the patient no longer
responds, at least at the level of shock strength that has been used on
them. For these individuals, even immediate interruption of behavior
may not result from use of shocks. Experts in the field consider
adaptation to be evidence of ineffectiveness (see 85 FR 13312 at 13336
and 81 FR 24386 at 24399). JRC has acknowledged that adaptation may
necessitate an alternative method to modify behaviors instead of an ESD
(see 85 FR 13312 at 13336). As we stated in the 2020 Final Rule, JRC's
Director of Research at the time said JRC had ``a very comprehensive
alternative behavior program'' that was ``very effective'' after
adaptation to the stronger version of JRC's ESD, even for patients
engaging in SIB that could result in serious injury to themselves (85
FR 13312 at 13336). That JRC's own providers ultimately turn to
alternative behavioral programs, even for severe behaviors, speaks both
to the effectiveness of state-of-the-art approaches and the
ineffectiveness of applying electrical shocks for SIB or AB.
[[Page 20891]]
Considering such evidence in the previous rulemaking, FDA concluded
that the limited data regarding the effects of ESDs for SIB or AB are
inadequate to demonstrate that ESDs are effective for durable behavior
conditioning. For more information about FDA's previous determination
regarding the effects of ESDs on SIB and AB, see section V.D. of the
2020 Final Rule (85 FR 13312 at 13332 through 13337).
The information in the new sources does not change the Agency's
prior determinations about the short- and long-term effects of ESDs on
SIB or AB. Most of the new studies are authored or coauthored by JRC
staff and appear to be based on much of the same or similar data JRC
previously submitted, with similar limitations, albeit presented in a
different format. As with the studies FDA reviewed for the 2020 Final
Rule, the new studies similarly suggest some immediate effects of ESDs
for SIB or AB for some individuals, in particular that the ESDs
interrupted the target behavior (Refs. 8 to 12). Some commentaries,
consensus statements, the ABAI task force report, and the 88-patient
survey also offer some support for the immediate effect of ESDs on
targeted behavior (although some individuals may not respond and/or may
adapt to the shock intensity and alternative approaches are used)
(Refs. 3, 5, 7, 14, 18, and 19). The new studies also conclude that
ESDs have some level of durable effectiveness for some individuals with
SIB and AB. Relying on information that FDA previously reviewed and
some of the new studies discussed in this proposed rule, the ABAI task
force similarly states that ESDs ``can be effective in suppressing
problem behavior for up to 5 years'' and that ``responding typically
remains suppressed under [ESDs] over the long run'' (Ref. 7). However,
due to the various limitations of these studies as well as the evidence
indicating adaptation to the device and potentially unending ESD use
for some individuals, FDA has determined that the evidence still does
not demonstrate that the devices are effective for durable behavior
conditioning for SIB or AB for a clinically meaningful period of time,
much less that they present a favorable benefit-risk profile.
The new studies suffer from many of the same limitations as those
studies FDA considered and discussed in the 2016 Proposed Rule and 2020
Final Rule. The three case report studies (Refs. 8, 11, and 12) and one
open label add-on trial (Ref. 10) involve a very small number of
patients (one to four), which makes generalization of any results
difficult. Four of the five new studies were authored or coauthored by
JRC staff, which may introduce researcher bias. All of the studies lack
robust experimental controls and, as explained above, likely
underreport AEs.
The new studies also include significant confounding factors, such
as the presence of concurrent treatments or changes in other treatments
over a period of time. The JRC 173-patient retrospective chart review
acknowledges that, ``[d]uring treatment, a given participant may have
received additional treatments including psychotherapy,
psychopharmacology, and/or various behavioral interventions.'' The ABAI
task force report describes one example of an additional treatment, a
``holster program,'' used by JRC in some cases where a patient adapts
or does not respond to the GED-4 to decrease problem behavior (see also
Ref. 8). Individuals in the program receive continuous access to a
positive reward (preferred videos, music, etc.) for keeping their hands
in a holster for increasing amounts of time. If they remove their
hands, the reward will stop, and a shock will be administered. Once the
individuals can keep their hands in the holsters for 10 minutes, they
continue to receive regular ``practice sessions'' to ``maintain the
effectiveness of holster-wearing to decrease problem behavior
throughout the remainder of the day.'' While wearing the holster during
the day, if a target behavior occurs, the individual receives a shock
and a 10-minute holster session (Ref. 7). The description of the
holster program, while unclear in some particulars, suggests that
increasing opportunities for positive reinforcement supports any
reduction of target behaviors. The use of this positive reinforcement
method introduces a confounding factor in the determination of the
effectiveness of ESDs; the reward system, rather than the ESD, may have
induced or helped induce any desirable effects on behavior.
Alternatively, or perhaps as a complement to the reward system, use of
the holster may have controlled or helped control the behavior. Other
concurrent treatments or changes to treatments may have similar
confounding effects.
Another limitation of some of the new studies stems from the fact
that the behaviors targeted for ESD use are not consistent across the
studies, and they were not limited to SIB or AB. Target behaviors
spanned a wide range, such as ``members of a chain of behaviors (e.g.,
posturing and threats) that consistently led to the ultimate behavior,
attempts to engage in the behavior, and vestigial versions of the
behavior'' (Ref. 9). Thus, vaguely described improvements that may, for
example, include reductions in ``vestigial versions of the behavior''
are not obviously evidence of effectiveness for treating SIB or AB.
Such claims also speak to a vulnerable population being subject to
invasive behavioral control techniques; that is, such claims may also
speak to an increased risk of AEs from an overly broad set of targeted
behaviors. The sources also indicate that ESDs may be used for other
categories of behavior such as noncompliant, destructive, and major
disruptive behaviors as well as attempts to remove the device (Refs. 7,
9, and 11). Delivering an electric shock, for instance, for disruptive
behavior is not clearly addressing self-injury or aggression. In the
same vein, use of the device in an attempt to prevent its removal is
not only difficult to rely on as evidence of effectiveness for SIB or
AB, but such use also underscores that vulnerable patients are unable
to avoid the risks presented by the device, such as pain. This in turn
can increase other risks, such as the risk of learned helplessness
(Ref. 20). Such broad target behaviors also suggest that a population
broader than individuals exhibiting SIB and AB may be subject to the
invasive behavioral control of ESDs and the risks they present.
Some studies acknowledge these methodological limitations. The JRC
173-patient retrospective chart review (Ref. 9) explains that ``a wide
range of behavior topographies [were] targeted'' because they ``were
associated with aggression and self-injury,'' and the ``participants
lacked homogeneity outside of the uniting factor of behavior problem
severity and refractory nature.'' In other words, the study included
participants with widely differing behavioral characteristics, although
their severity was considered similar. The study also recognizes,
``[t]he participants carried a variety of diagnoses and may have
responded differently because of their diagnostic classification'' and
``[v]arious pathophysiological and environmental determinants may lead
to such behaviors.'' This study also noted, ``the frequency data lacks
interobserver reliability,'' meaning it did not account for or address
variability between different observers' subjective judgments. The open
label add-on trial (Ref. 10) identifies some of the same limitations
that make it difficult to conclude that any observed reductions in
target behavior are evidence of effectiveness of ESDs for SIB or AB.
[[Page 20892]]
New evidence regarding the lengthy, often indefinite, time periods
that ESDs have been used on individuals and the adaptation of some
individuals to the shocks further supports our determination that ESDs
have not been demonstrated to be effective. For example, a four-patient
case report study suggests that, for some patients, ESDs would be
indicated indefinitely, similar to insulin for diabetes or
antiarrhythmic and antihypertensive drugs for cardiovascular disease
(Ref. 8). The ABAI task force reports that JRC's approach is that
``most clients will need to receive treatment [with ESDs] for lengthy
periods of time (5 to 20 years)'' and that ``this does not appear to be
a treatment that can be effectively faded or discontinued quickly''
(Ref. 7). This suggests that the device is not effective for durable
behavior conditioning for SIB or AB, and is, therefore, not effective
for its intended use.
The new sources also support FDA's previous finding that ESDs may
even lose any immediate effect for some individuals exhibiting SIB or
AB. The 173-patient retrospective chart review from JRC reports that
for some participants the ``GED lost efficacy or was only partially
effective and was substituted for [sic] a more intense stimulus (GED-
4)'' (Ref. 9). The authors note that adaptation was consistent with
earlier studies that identified habituation to shock intensity by some
patients and the need for more-intense shocks to eliminate targeted
behavior. The JRC four patient case report study noted this effect in
one patient (Ref. 8). The ABAI task force also reported adaptation to
the ESD based on a visit by members spanning 2 full days in July 2022
to assess JRC's use of ESDs. The report states that ``[i]n some cases,
the intensity of the shock must be increased to improve and/or maintain
its efficacy'' and ``a [JRC] client will be moved from the GED-3 to the
GED-4 if the GED-3 does not reduce the behavior sufficiently or if the
client's behavior begins to show habituation to the GED-3'' (Ref. 7).
According to the report, patients can even habituate, or may not
respond to, shocks from the GED-4, which provides shocks that are
significantly stronger than those provided by the GED-3 (41 milliampere
(mA) vs. 15 mA).
As a result of such weaknesses and limitations, the available data,
including the data and information in the new studies and other
materials, are not sufficient to demonstrate that ESDs for SIB or AB
are effective for durable behavior conditioning or that they have a
favorable benefit-risk profile.
Based upon all available information and data, FDA continues to
find that while ESDs may result in the interruption and immediate
cessation of SIB and AB for some individuals if the individual has not
adapted to the shocks, ESDs have not been demonstrated to be effective
at improving the underlying condition or conditioning an individual to
achieve a durable reduction of SIB or AB for a clinically meaningful
period of time. The evidence does not establish a favorable benefit-
risk profile, and the newer evidence suggesting indefinite use of the
devices for ongoing management of symptoms may indicate a worse
benefit-risk profile.
C. State of the Art for Treating SIB or AB
In determining whether a device presents an unreasonable and
substantial risk of illness or injury, FDA analyzes the risks and
benefits that the device poses to individuals relative to the state-of-
the-art of treatment for the intended population--that is, the current
state of technical and scientific knowledge and medical practice, and
the potential hazard to patients and users. As explained in the 2020
Final Rule, FDA found that scientific and medical advances, concerns
for ethical treatment, and a desire to create generalizable
interventions that work in community settings led behavioral scientists
to develop treatments for SIB and AB that are low risk and have
generally been successful. The available information indicated that
state-of-the-art treatments of SIB or AB are multielement positive
interventions (e.g., paradigms such as PBS or DBT), sometimes in
conjunction with pharmacological treatments, as appropriate (85 FR
13312 at 13341; 81 FR 24386 at 24410). When restrictive elements or
punishment techniques were used, they supplemented other behavioral
intervention elements, were much less intrusive, and were not painful;
they were considered both compatible with PBS and beneficial (see 85 FR
13312 at 13341).
As we said in the 2020 Final Rule, the use of ESDs does not teach a
person new skills or replacement behaviors, does not mitigate the
underlying cause of their SIB or AB, and has not been demonstrated to
be effective for behavioral conditioning, which is especially difficult
to achieve for those who have conditions that impair their ability to
understand consequences and react by changing their behaviors. These
are some of the reasons that the field of applied behavior analysis
(ABA) as a whole moved away from highly intrusive physical aversive
conditioning techniques such as ESDs decades ago (85 FR 13312 at
13340).
FDA determined that although positive behavioral interventions may
not always be completely successful in all patients, positive-only
approaches have low risk and are typically successful, on their own or
in conjunction with pharmacotherapy, regardless of the severity of the
behavior targeted or the setting, and can achieve durable long-term
results while avoiding the risks posed by ESDs (85 FR 13312 at 13315).
As noted above, when practitioners felt punishment techniques were
helpful, such techniques were much less intrusive than the use of ESDs;
for example, they included timeouts, holds, and facial screening (85 FR
13312 at 13341). For a detailed description of FDA's assessment of
state-of-the-art treatments for SIB and AB for the 2020 Final Rule, see
section V.E. of the 2020 Final Rule (85 FR 13312 at 13337 through
13344) and section II.C. of the 2016 Proposed Rule (81 FR 24386 at
24403 through 24410).
The evidence still indicates that positive-only approaches, such as
approaches based on differential reinforcement and skill-based
instruction, have been shown to be highly successful in treating many
types of severe problem behaviors (Ref. 7). Even when ESDs are used for
SIB or AB, they generally are supplemented by state-of-the-art and/or
other less intrusive approaches even for severe cases (Ref. 9). An
example of an alternative treatment that practitioners may turn to if
an individual habituates to the strongest ESD available is the holster
program, which is a less intrusive paradigm that increases the use of
positive rewards. In short, to the extent new information and data bear
on the state of the art, they underscore why the field as a whole has,
for decades (81 FR 24386 at 24387), moved away from ESDs and turned
toward less intrusive techniques to treat SIB or AB effectively (Ref.
21). Further, the newer information and data emphasize that ESDs are
not in fact treatments of last resort, even at the facility that has
previously made such claims. As discussed further in section V.C., the
ABAI task force reports that JRC rarely conducts analogue functional
analyses (FAs), despite the fact that experts consider FA the ``gold
standard'' assessment strategy for problem behavior (Ref. 7). This
practice suggests that individuals may not experience the ``almost
unlimited'' range of alternative treatments available (Ref. 7) based on
an up-to-date, location-specific, comprehensive FA prior to JRC
[[Page 20893]]
incorporating ESDs into their treatment plan. This failure to
systematically identify and exhaustively implement alternatives
undercuts the certainty that JRC's patients would not respond to less
intrusive treatment, are uniquely refractory, and that the devices are
applied as a last resort, as is suggested by the device labeling.\4\
---------------------------------------------------------------------------
\4\ The labeling of GED devices includes the statement that
``[t]he device should be used only on patients where alternate forms
of therapy have been attempted and failed'' (81 FR 24386 at 24412).
---------------------------------------------------------------------------
Thus, FDA concludes that state-of-the-art treatment for SIB and AB
involves positive behavioral techniques, with or without
pharmacotherapy, and that positive-only approaches have low risk and
are generally successful even for challenging SIB and AB, in both
clinical and community settings. Moreover, when punishment techniques
are used in state-of-the-art behavior modification plans, they are not
painful and are much less intrusive.
D. Labeling and Correcting or Eliminating Substantial and Unreasonable
Risks
After considering all available data and information for the 2020
Final Rule, FDA determined that labeling or a change in labeling cannot
correct or eliminate the unreasonable and substantial risk of illness
or injury of ESDs for SIB or AB (85 FR 13312 at 13344 and 13345). FDA
further determined that labeling cannot limit the risks to only the
most refractory patients. The only ESDs for SIB or AB that are
currently in use, two models of GED manufactured and used by JRC, are
labeled for use only in individuals refractory to other treatments.
Such a subpopulation is difficult or impossible to define (85 FR 13312
at 13332). Further, FDA found the available evidence casts doubt on
whether the devices are in fact applied as a last resort after
attempting all other approaches as indicated in the labeling (and as
claimed by one commenter on the previous proposed rule (JRC)) (Ref.
22). These determinations remain true after FDA's updated review of the
available literature.
More importantly, no subpopulation has been identified in which
ESDs are effective for SIB or AB or do not pose the risks identified in
the previous rulemaking and discussed earlier in this document. There
are also no data suggesting ESDs are more likely to be effective for
SIB or AB or less likely to pose these risks in a subpopulation that is
refractory to other treatments or in any other subpopulation.
Regardless of how the device is labeled, the individual subject to it
will receive shocks intended to be painful and thereby be subject to
the physical and psychological risks described in section V.A above,
without demonstrated effectiveness (see also 85 FR 13312 at 13344).
Further, individuals with intellectual or developmental
disabilities may not communicate or be able to communicate information
for the device user to change the manner in which the device is used to
correct or eliminate the risks (81 FR 24386 at 24412; 85 FR 13312 at
13344). Impaired communication of the effects of the device further
prevents labeling from reducing risks. Accordingly, we concluded that
no manner of labeling will correct or eliminate the substantial and
unreasonable risks of these devices (see 81 FR 24386 at 24411 and
24412; 85 FR 13312 at 13344).
No additional information has come to FDA's attention indicating
that labeling or a change in labeling can correct or eliminate the
substantial and unreasonable risks of these devices. As noted in
section V.C., the new evidence indicates that JRC rarely conducts FAs
of patients. This absence of FAs conducted by JRC suggests that the
existing limiting language in the labeling has little effect on
mitigating risks by focusing on refractory cases. Indeed, as discussed
more in section V.B. above, refractory cases at JRC are ultimately
treated with less invasive approaches suggesting that as used, ESDs are
not a treatment of last resort. This reinforces our prior
determinations that labeling specifying a refractory population would
not correct or eliminate the substantial and unreasonable risk, and
that there are no labeling changes that would mitigate the risks posed
by these ESDs.
Finally, as explained above and in the 2020 Final Rule, no manner
of labeling will correct or eliminate the risks for patients receiving
shocks, many of whom may not communicate or be able to communicate
information about AEs as a result of intellectual or developmental
disabilities (85 FR 13312 at 13344). The device will continue to
present the same unreasonable and substantial risk of illness or injury
for these individuals regardless of the labeling. Based on this
information and data, FDA concludes that labeling, or a change in
labeling, cannot correct or eliminate the unreasonable and substantial
risk of illness or injury of ESDs for SIB or AB.
VI. Description of the Proposed Rule
We are proposing to amend part 895 by adding Sec. 895.105 to ban
ESDs for SIB or AB. The proposed rule would ban ESDs intended to treat
patients with SIB or AB and would cause ESDs intended for these uses
not to be legally marketed devices, for example, under section 1006 of
the FD&C Act. We are also proposing conforming edits to Sec. 882.5235
to exclude ESDs for SIB or AB from the class II designation for
aversive conditioning devices and instead to indicate that ESDs for SIB
or AB are banned devices.
A. Applicability (Proposed Sec. 895.105)
FDA is proposing to ban ESDs that apply a noxious electrical
stimulus to a person's skin to reduce or stop aggressive or self-
injurious behavior. FDA has determined that these devices present an
unreasonable and substantial risk of illness or injury that cannot be
corrected or eliminated by labeling. FDA is not proposing to ban ESDs
intended for other purposes, such as smoking cessation. ESDs are not
used in electroconvulsive therapy, sometimes called electroshock
therapy or ECT, which is unrelated to this rulemaking.
1. Distinguishing Technologically Similar Devices With Different
Intended Uses
Note that, although ESDs for SIB or AB may have parallels in
technology and behavior modification strategy as ESDs for other
intended uses, ESDs for SIB or AB are distinguishable from other ESDs
based on several factors. These factors include device design; whether
patients have control over the shocks and what level of control they
have; the power output and resulting intensity of the electric shock;
and how the electric shock affects the patient, target behavior, and
underlying conditions. For example, a smoking cessation device would
generally have different output characteristics, resulting in a less
noxious (perhaps non-painful) shock, where the person affected by the
shock retains complete control of application of shocks (or could
immediately revoke consent to the application of shocks). Use of such a
device without modification for SIB or AB would not be expected to
induce a response for SIB or AB.
In contrast, patients exhibiting SIB or AB have no control over
devices intended for these uses and these devices often deliver a
painful or very painful shock, strong enough to induce fear and other
reactions, as opposed to a milder shock from other ESDs. The SIB or AB
patient is made to carry a stimulus generation module in a waist-pack
or backpack 24 hours a day, 7 days a week, except during attempts to
``fade'' the device (although the user,
[[Page 20894]]
not the patient, still decides whether to apply and trigger the
device). Depending on the targeted behavior, ESDs for SIB or AB use up
to five electrodes strapped to the arms, legs, torso, and/or feet
simultaneously, but the locations are not of the patient's choosing
(see Ref. 7). Shocks are from one electrode at a time, and the
electrodes are rotated every hour or after discharge, but the patients
are not able to dictate the rotation for themselves (see Ref. 7).
Patients subject to ESDs for SIB or AB also have no control over
whether to withdraw from treatment. Even for patients with mild to no
intellectual disabilities, evidence indicates that assent from the
patient is not sought (see Ref. 7). As explained in the 2020 Final
Rule, lack of control over multiple shocks is an additional risk factor
because learned helplessness may be more likely when the recipient does
not have control over the shocks and has previously received multiple
shocks (85 FR 13312 at 13326). When the recipient does not have control
over the shocks and has previously received multiple such shocks,
psychological trauma such as an anxiety or panic reaction can result
even when the strength is relatively modest (see 85 FR 13312 at 13324
through 13327).
Moreover, as explained in the 2020 Final Rule, devices with similar
technology intended for other uses address different conditions or
behaviors in different patient populations, and as a result, they
present different benefit-risk profiles. A device that presents certain
risks or benefits for one population may not present the same risks or
benefits, or present them to the same degree, or may present different
risks or benefits, for a different population. An important
consideration in the benefit-risk profile of a device is the intended
patient population and their vulnerabilities. The intended use
population for ESDs for SIB or AB includes a significant number of
individuals who have disabilities that present vulnerabilities, such as
difficulty communicating pain and other harms caused by ESDs. As a
result of these vulnerabilities, the individual may not communicate or
be able to communicate information for the device user to change the
manner in which the device is used to correct or eliminate the risks
(85 FR 13312 at 13344). In addition, people who exhibit SIB or AB may
not be able to associate cause and effect or, as with some people with
an autism spectrum disorder (ASD), they may express pain atypically or
not at all (85 FR 13312 at 13317). These vulnerabilities are not likely
to be present in people who use ESDs for other purposes. As a result,
individuals subject to shocks from an ESD for SIB or AB would bear a
higher risk of injury or illness from the shock than, for example,
smokers who choose to use an ESD to help quit smoking (81 FR 24386 at
24395). Smokers can immediately communicate pain to the device's
controller or remove the device themselves. They can communicate
symptoms of other harms that may be caused by ESDs to their healthcare
provider, which may lead to discontinuation of the device's use, or
they can decide to stop using the device (85 FR 13312 at 13317).
2. Banning ESDs for SIB or AB That Are Already in Commercial
Distribution
FDA is proposing that the ban apply to devices already in
commercial distribution and use, as well as devices sold or
commercially distributed in the future (see Sec. 895.21(d)(7)). This
means ESDs for SIB or AB currently in use on individuals would be
subject to the ban and thus, upon the effective date of the final rule,
adulterated under section 501(g) of the FD&C Act and subject to
potential FDA enforcement action. FDA is proposing this because the
risk of illness or injury to individuals on whom these devices are
already used is just as unreasonable and substantial as it is for
future individuals on whom these devices could be used. Indeed, as the
development of more beneficial, lower-risk alternative treatments
continues, the ban's mitigation of the substantial and unreasonable
risk may be greatest for the individuals on whom ESDs are currently
used.
However, as explained in the 2020 Final Rule, for devices already
in use for SIB or AB, in light of concerns about thorough assessments
of the behaviors' functions and corresponding development of
appropriate treatment plans, FDA recognizes that affected parties may
need some period of time to establish or adjust treatment plans (85 FR
13312 at 13349). FDA believes that transition off ESDs should occur
under the supervision of a physician and that the transition should
occur as soon as possible for the individual. FDA is proposing, for
devices in use on specific individuals as of the date of publication of
any final rule based on this proposal, and subject to a physician-
directed transition plan, compliance would be required 180 days after
the date of publication of any final rule. We welcome comment on how
long transitions may take.
B. Proposed Conforming Amendment (Sec. 882.5235)
We are proposing conforming edits to paragraph (b) of Sec.
882.5235 to exclude ESDs for SIB or AB from the classification of
aversive conditioning devices into class II. This amendment would
indicate that ESDs for SIB or AB are banned devices rather than class
II devices.
VII. Proposed Effective and Compliance Dates
FDA proposes that any final rule based on this proposed rule be
effective 30 days after its date of publication in the Federal
Register.
FDA proposes that, for devices in use on specific individuals as of
the date of publication of the final rule and subject to a physician-
directed transition plan, compliance be required 180 days after the
date of publication of the final rule in the Federal Register. For all
other devices, FDA proposes that compliance be required 30 days after
publication in the Federal Register.
VIII. Preliminary Economic Analysis of Impacts
A. Introduction
We have examined the impacts of the proposed rule under Executive
Order 12866, Executive Order 13563, Executive Order 14094, the
Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4).
Executive Orders 12866, 13563, and 14094 direct us to assess all
benefits, costs, and transfers of available regulatory alternatives
and, when regulation is necessary, to select regulatory approaches that
maximize net benefits (including potential economic, environmental,
public health and safety, and other advantages; distributive impacts;
and equity). Rules are ``significant'' under Executive Order 12866
Section 3(f)(1) (as amended by Executive Order 14094) if they ``have an
annual effect on the economy of $200 million or more (adjusted every 3
years by the Administrator of [the Office of Information and Regulatory
Affairs (OIRA)] for changes in gross domestic product); or adversely
affect in a material way the economy, a sector of the economy,
productivity, competition, jobs, the environment, public health or
safety, or State, local, territorial, or tribal governments or
communities.'' OIRA has determined that this proposed rule is not a
significant regulatory action under Executive Order 12866 Section
3(f)(1).
The Regulatory Flexibility Act requires us to analyze regulatory
options
[[Page 20895]]
that would minimize any significant impact of a rule on small entities.
Because the proposed rule would only affect one entity--one that is not
classified as small--we propose to certify that the proposed rule will
not have a significant economic impact on a substantial number of small
entities.
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes estimates of
anticipated impacts, before proposing ``any rule that includes any
Federal mandate that may result in the expenditure by State, local, and
tribal governments, in the aggregate, or by the private sector, of
$100,000,000 or more (adjusted annually for inflation) in any one
year.'' The 2022 threshold after adjustment for inflation is $177
million, using the 2022 Implicit Price Deflator for the Gross Domestic
Product. This proposed rule would not result in an expenditure in any
year that meets or exceeds this amount.
B. Summary of Benefits, Costs, and Transfers
The proposed rule, if finalized, would ban ESDs used for self-
injurious or aggressive behavior. FDA has determined that these devices
present an unreasonable and substantial risk of illness or injury that
cannot be corrected or eliminated by labeling or a change in labeling.
The proposed rule would apply to devices already in distribution and
use, as well as to future sales and commercial distribution of these
devices. The costs associated with this proposed rule include costs of
individuals who are subject to the device if they move to another
facility or another program within the affected entities. Affected
entities, who use the device on such individuals, would also incur
costs from reading and understanding the rule. The present value of
total estimated costs range between $0.00 million and $68.93 million at
a 7 percent discount rate, with a primary estimate of $34.47 million.
At a 3 percent discount rate, the present value of costs range between
$0.00 million and $80.59 million, with a primary estimate of $40.3
million. We estimate that the annualized costs over 10 years would
range from $0.00 million to $9.17 million with a primary estimate of
$4.59 million at a 7 percent discount rate and a 3 percent discount
rate.
The benefits would include avoided negative physical and
psychological effects from using ESDs on individuals and benefits to
society in terms of protecting vulnerable populations, which we are not
able to quantify. We estimate that between 51 to 54 individuals would
be affected by the proposed rule, if finalized, and benefit from
avoided adverse effects associated with using ESDs. Any transfers
associated with the rule would occur if individuals enroll at
facilities other than the affected entities. The present value of total
transfer ranges between $0.00 million and $118.26 million at a 7
percent discount rate, with a primary estimate of $59.13 million. At a
3 percent discount rate, the present value of transfers ranges between
$0.00 million and $138.26 million, with a primary estimate of $69.13
million. The annualized value of transfers range between $0.00 million
and $15.74 million, with a primary estimate of $7.87 million, at both 7
percent and 3 percent discount rates. We provide a summary of the
benefits, costs, and transfers of the proposed rule, if finalized, in
table 1. We request comment on our estimates of benefits, costs, and
transfers of this proposed rule.
Table 1--Summary of Benefits, Costs, and Distributional Effects of the Proposed Rule
[Millions of 2022 dollars]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Units
Primary Low High ----------------------------------------------------------
Category estimate estimate estimate Discount Notes
Year dollar rate Period covered
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
Annualized Monetized ($m/year).......... ........... ........... ........... ........... 7%
3%
Annualized Quantified................... ........... ........... ........... ........... 7%
3%
-----------------------------------------------------------------------------------------------------------
Qualitative................................. Reduction in injuries or adverse psychological effects of ESDs on individuals subject to the
device.
-----------------------------------------------------------------------------------------------------------
Costs:
Annualized Monetized ($m/year).......... $4.59 $0.00 $9.17 2022 7% 10 years
$4.59 $0.00 $9.17 2022 3% 10 years......................
Annualized Quantified................... ........... ........... ........... ........... 7%
3%
-----------------------------------------------------------------------------------------------------------
Qualitative............................. Transition costs to affected entities and individuals for transitioning to alternative
treatments.
-----------------------------------------------------------------------------------------------------------
Transfers:
Federal Annualized Monetized ($m/year).. ........... ........... ........... ........... 7%
3%
Other Annualized Monetized ($m/year).... $7.87 $0.00 $15.74 2022 7% 10 years
$7.87 $0.00 $15.74 2022 3% 10 years......................
-----------------------------------------------------------------------------------------------------------
From: Affected entities that
currently use the device
To: Other facilities that treat
aggressive or self-injurious behavior
-----------------------------------------------------------------------------------------------------------
Effects: State, Local, or Tribal Government: State expenditures may rise or fall if individuals move
across state boundaries
-----------------------------------------------------------------------------------------------------------
Small Business: No effect
-----------------------------------------------------------------------------------------------------------
Wages: No effect
Growth: No effect
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 20896]]
We have developed a comprehensive Preliminary Economic Analysis of
Impacts that assesses the impacts of the proposed rule. The full
preliminary analysis of economic impacts is available in the docket for
this proposed rule (Ref. 23) and at <a href="https://www.fda.gov/about-fda/economics-staff/regulatory-impact-analyses-ria">https://www.fda.gov/about-fda/economics-staff/regulatory-impact-analyses-ria</a>.
IX. Analysis of Environmental Impact
FDA has carefully considered the potential environmental effects of
this proposed rule and of possible alternative actions. In doing so,
the Agency focused on the environmental impacts of its action as a
result of disposal of unused ESDs that will need to be handled after
the effective date of the final rule.
The environmental assessment (EA) considered each of the
alternatives in terms of the need to provide maximum reasonable
protection of human health without resulting in a significant impact on
the environment. The EA considered environmental impacts related to
landfill and incineration of solid waste at municipal solid waste (MSW)
facilities. The proposed action will result in an initial batch
disposal of used and unused ESDs primarily at a single geographic and
affiliated locations followed by a gradual, intermittent disposal of a
small number of remaining devices in this and other affected
communities where these devices are used. The total number of devices
to be disposed is small, i.e., approximately less than 300 units.
Overall, given the limited number of ESDs in commerce, the proposed
action is expected to have no significant impact on MSW and landfill
facilities and the environment in affected communities.
The Agency has concluded that the proposed rule will not have a
significant impact on the human environment, and that an environmental
impact statement is not required. FDA's finding of no significant
impact (FONSI) and the evidence supporting that finding, contained in
an EA prepared under 21 CFR 25.40, may be seen in the Dockets
Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday
through Friday; they are also available electronically at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. FDA invites comments and submission of data
concerning the EA and FONSI.
X. Paperwork Reduction Act of 1995
FDA tentatively concludes that this proposed rule contains no
collection of information. Therefore, clearance by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 is not
required.
XI. Federalism
FDA has analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. Section 4(a) of the
Executive order requires Agencies to ``construe . . . a Federal statute
to preempt State law only where the statute contains an express
preemption provision or there is some other clear evidence that the
Congress intended preemption of State law, or where the exercise of
State authority conflicts with the exercise of Federal authority under
the Federal statute.'' Federal law includes an express preemption
provision that preempts certain State requirements ``different from or
in addition to'' certain Federal requirements applicable to devices
(see section 521 of the FD&C Act (21 U.S.C. 360k); Medtronic v. Lohr,
518 U.S. 470 (1996); and Riegel v. Medtronic, 128 S. Ct. 999 (2008)).
If this proposed rule is made final, it would create a Federal
requirement under section 521 of the FD&C Act that bans ESDs for SIB or
AB.
XII. Consultation and Coordination With Indian Tribal Governments
We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13175. We have tentatively
determined that the rule does not contain policies that would have a
substantial direct effect on one or more Indian Tribes, on the
relationship between the Federal Government and Indian Tribes, or on
the distribution of power and responsibilities between the Federal
Government and Indian Tribes. The Agency solicits comments from tribal
officials on any potential impact on Indian Tribes from this proposed
action.
XIII. References
The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (see ADDRESSES) and are available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they also are available electronically at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. References without asterisks are not on public
display at <a href="https://www.regulations.gov">https://www.regulations.gov</a> because they have copyright
restriction. Some may be available at the website address, if listed.
References without asterisks are available for viewing only at the
Dockets Management Staff. Although FDA verified the website addresses
in this document, please note that websites are subject to change over
time.
*1. FDA, ``Meeting Materials of the Neurological Devices
Panel.'' April 24, 2014. Available at: <a href="https://wayback.archive-it.org/7993/20170405192749/https:/www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/NeurologicalDevicesPanel/ucm394252.htm">https://wayback.archive-it.org/7993/20170405192749/https:/www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/NeurologicalDevicesPanel/ucm394252.htm</a>.
2. Bottema-Beutel, K., S. Crowley, M. Sandbank, et al. ``Adverse
Event Reporting in Intervention Research for Young Autistic
Children.'' Autism, 25:322-335, 2021. Available at: <a href="https://doi.org/10.1177/1362361320965331">https://doi.org/10.1177/1362361320965331</a>.
3. Blenkush, N.A. ``A Risk-Benefit Analysis of Antipsychotic
Medication and Contingent Skin Shock for the Treatment of
Destructive Behaviors.'' International Journal of Psychology &
Behavior Analysis, 3(121):1-14, 2017. Available at: <a href="https://doi.org/10.15344/2455-3867/2017/121">https://doi.org/10.15344/2455-3867/2017/121</a>.
4. Schuck, R.K., D.M. Tagavi, K.M.P. Baiden, et al.
``Neurodiversity and Autism Intervention: Reconciling Perspectives
Through a Naturalistic Developmental Behavioral Intervention
Framework.'' Journal of Autism and Developmental Disorders,
52(10):4625-4645, October 13, 2021. Available at: <a href="https://doi.org/10.1007/s10803-021-05316-x">https://doi.org/10.1007/s10803-021-05316-x</a>.
5. Zarcone, J.R., M.P. Mullane, P.E. Langdon, et al.
``Contingent Electric Shock as a Treatment for Challenging Behavior
for People With Intellectual and Developmental Disabilities: Support
for the IASSIDD Policy Statement Opposing Its Use.'' Journal of
Policy and Practice in Intellectual Disabilities, 17(4):291-296,
2020. Available at: <a href="https://doi.org/10.1111/jppi.12342">https://doi.org/10.1111/jppi.12342</a>.
6. Mercer, J. ``Evidence of Potentially Harmful Psychological
Treatments for Children and Adolescents.'' Child and Adolescent
Social Work Journal, 34(2):107-125, 2017. Available at: <a href="https://doi.org/10.1007/s10560-016-0480-2">https://doi.org/10.1007/s10560-016-0480-2</a>.
7. Perone, M., D.C. Lerman, S.M. Peterson, et al. ``Report of
the ABAI Task Force on Contingent Electric Skin Shock.''
Perspectives on Behavior Science, 46(2):261-304, 2023. Available at:
<a href="https://doi.org/10.1007/s40614-023-00379-w">https://doi.org/10.1007/s40614-023-00379-w</a>.
8. Yadollahikhales, G., N. Blenkush, and M. Cunningham.
``Response Patterns for Individuals Receiving Contingent Skin Shock
Aversion Intervention To Treat Violent Self-Injurious and Assaultive
Behaviours.'' BMJ Case Reports CP, 14(5):e241204, 2021. Available
at: <a href="http://dx.doi.org/10.1136/bcr-2020-241204">http://dx.doi.org/10.1136/bcr-2020-241204</a>.
9. Blenkush, N.A. and J. O'Neill. ``Contingent Skin-Shock
Treatment in 173 Cases of Severe Problem Behavior.'' International
Journal of Psychology & Behavior Analysis, 6:167, 2020. Available
at: <a href="https://doi.org/10.15344/2455-3867/2020/167">https://doi.org/10.15344/2455-3867/2020/167</a>.
10. O'Neill, J. and N. Blenkush. ``Contingent Skin-Shock
Treatment and the Reversal of Effects on Severe Problem Behavior.''
International Journal of Psychology & Behavior Analysis, 6:168,
2020. Available at: <a href="https://doi.org/10.15344/2455-3867/2020/168">https://doi.org/10.15344/2455-3867/2020/168</a>.
11. Blenkush, N. and M. Cunningham. ``Elimination of Refractory
Aggression and
[[Page 20897]]
Self-Injury With Contingent Skin Shock.'' The Journal of
Neuropsychiatry and Clinical Neurosciences, 35:264-268, 2023.
Available at: <a href="https://doi.org/10.1176/appi.neuropsych.21020049">https://doi.org/10.1176/appi.neuropsych.21020049</a>.
12. Salerno, J. ``Efficacy, Risks, and Ethics of Aversive or
Positive Therapy in Identical Twins.'' Ph.D. diss., Walden
University, 2019. Available at: <a href="https://scholarworks.waldenu.edu/dissertations/6946">https://scholarworks.waldenu.edu/dissertations/6946</a>.
13. Dawson, M. and S. Fletcher-Watson. ``When Autism Researchers
Disregard Harms: A Commentary.'' Autism, 26(2):564-566, 2022.
Available at: <a href="https://doi.org/10.1177/13623613211031403">https://doi.org/10.1177/13623613211031403</a>.
14. Foxx, R.M. ``The National Institutes of Health Consensus
Development Conference on the Treatment of Destructive Behaviors: A
25-Year Update of a Study in Hardball Politics.'' In: Controversial
Therapies for Autism and Intellectual Disabilities (Second ed.). New
York, NY: Routledge; part VI, chapter 27, pp. 451-471, 2016. Foxx,
R.M. and J.A. Mulick (Eds.) Available at: <a href="https://www.routledge.com/Controversial-Therapies-for-Autism-and-Intellectual-Disabilities-Fad-Fashion/Foxx-Mulick/p/book/9781138802230">https://www.routledge.com/Controversial-Therapies-for-Autism-and-Intellectual-Disabilities-Fad-Fashion/Foxx-Mulick/p/book/9781138802230</a>.
15. Leaf, J.B., J.H. Cihon, R. Leaf, et al. ``Concerns About
ABA-Based Intervention: An Evaluation and Recommendations.'' Journal
of Autism and Developmental Disorders, 52(6):2838-2853, 2022.
Available at: <a href="https://doi.org/10.1007/s10803-021-05137-y">https://doi.org/10.1007/s10803-021-05137-y</a>.
16. Shkedy, G., D. Shkedy, and A.H. Sandoval-Norton. ``Treating
Self-Injurious Behaviors in Autism Spectrum Disorder.'' Cogent
Psychology, 6(1):1682766, 2019. Available at: <a href="https://doi.org/10.1080/23311908.2019.1682766">https://doi.org/10.1080/23311908.2019.1682766</a>.
17. Benevides T.W., S.M. Shore, K. Palmer, et al. ``Listening to
the autistic voice: Mental health priorities to guide research and
practice in autism from a stakeholder-driven project.'' Autism,
24(4):822-833, 2020. Available at <a href="https://doi.org/10.1177/1362361320908410">https://doi.org/10.1177/1362361320908410</a>.
18. Yadollahikhales, G., M. Cunningham, and N. Blenkush.
``Graduated Electrical Decelerator Effectiveness for Severe
Dangerous Behaviors in Autistic Children: Case Study.'' The Journal
of Neuropsychology and Clinical Neurosciences, 31(3): E28-E28, 2019.
Available at <a href="https://doi.org/10.1176/appi.neuropsych.18100235">https://doi.org/10.1176/appi.neuropsych.18100235</a>.
19. Lowther, N. and M. Newman. ``Does the Behavioral Progress
Made at JRC Generalize Across Settings and Over Time? A Follow-Up
Study of Former JRC Students.'' ABA, 2014.
20. M[uuml]ller M.J. ``Helplessness and Perceived Pain
Intensity: Relations to Cortisol Concentrations After
Electrocutaneous Stimulation in Healthy Young Men.'' BioPsychoSocial
Medicine, 5:1-7, 2011. Available at <a href="https://pubmed.ncbi.nlm.nih.gov/21718526/">https://pubmed.ncbi.nlm.nih.gov/21718526/</a>.
21. Association for Behavior Analysis International. ``Position
Statement on the Use of CESS.'' 2022. Available at <a href="https://www.abainternational.org/about-us/policies-and-positions/position-statement-on-the-use-of-cess-2022.aspx">https://www.abainternational.org/about-us/policies-and-positions/position-statement-on-the-use-of-cess-2022.aspx</a>. (Accessed August 18, 2023.)
*22. JRC, Inc., public docket comment to the 2016 Proposed Rule,
tracking number 1k0-8ref-d5le. Received July 25, 2016. Available at:
<a href="https://www.regulations.gov/comment/FDA-2016-N-1111-1637">https://www.regulations.gov/comment/FDA-2016-N-1111-1637</a>.
*23. ``Preliminary Regulatory Impact Analysis, Initial
Regulatory Flexibility Analysis, and Unfunded Mandates Reform Act
Analysis; Banned Devices; Proposal To Ban Electrical Stimulation
Devices for Self-Injurious or Aggressive Behavior''. Available at:
<a href="https://www.fda.gov/about-fda/economics-staff/regulatory-impact-analyses-ria">https://www.fda.gov/about-fda/economics-staff/regulatory-impact-analyses-ria</a>.
List of Subjects
21 CFR Part 882
Medical devices.
21 CFR Part 895
Administrative practice and procedure, Labeling, Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, we propose
that 21 CFR parts 882 and 895 be amended as follows:
PART 882--NEUROLOGICAL DEVICES
0
1. The authority citation for part 882 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. In Sec. 882.5235, revise paragraph (b) to read as follows:
Sec. 882.5235 Aversive conditioning device.
* * * * *
(b) Classification. Class II (special controls), except for
electrical stimulation devices for self-injurious or aggressive
behavior. Electrical stimulation devices for self-injurious or
aggressive behavior are banned. See Sec. 895.105 of this chapter.
PART 895--BANNED DEVICES
0
3. The authority citation for part 895 continues to read as follows:
Authority: 21 U.S.C. 352, 360f, 360h, 360i, 371.
0
4. Add Sec. 895.105 to subpart B to read as follows:
Sec. 895.105 Electrical stimulation devices for self-injurious or
aggressive behavior.
Electrical stimulation devices for self-injurious or aggressive
behavior are aversive conditioning devices that apply a noxious
electrical stimulus to a person's skin to reduce or cease self-
injurious or aggressive behavior.
Dated: March 12, 2024.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2024-06037 Filed 3-25-24; 8:45 am]
BILLING CODE 4164-01-P
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This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.