Rule2022-28603
Medical Devices; Neurological Devices; Classification of the Brain Stimulation Programming Planning Software
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
January 5, 2023
Effective
January 5, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is classifying brain stimulation programming planning software into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the brain stimulation programming planning software's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
Full Text
<html>
<head>
<title>Federal Register, Volume 88 Issue 3 (Thursday, January 5, 2023)</title>
</head>
<body><pre>
[Federal Register Volume 88, Number 3 (Thursday, January 5, 2023)]
[Rules and Regulations]
[Pages 749-751]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-28603]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 882
[Docket No. FDA-2022-N-3224]
Medical Devices; Neurological Devices; Classification of the
Brain Stimulation Programming Planning Software
AGENCY: Food and Drug Administration, HHS.
ACTION: Final amendment; final order.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
classifying brain stimulation programming planning software into class
II (special controls). The special controls that apply to the device
type are identified in this order and will be part of the codified
language for the brain stimulation programming planning software's
classification. We are taking this action because we have determined
that classifying the device into class II (special controls) will
provide a reasonable assurance of safety and effectiveness of the
device. We believe this action will also enhance patients' access to
beneficial innovative devices.
DATES: This order is effective January 5, 2023. The classification was
applicable on August 23, 2021.
FOR FURTHER INFORMATION CONTACT: Kristen Bowsher, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 4210, Silver Spring, MD, 20993-0002, 301-
796-6448, <a href="/cdn-cgi/l/email-protection#155e677c6661707b3b577a62667d7067557371743b7d7d663b727a63"><span class="__cf_email__" data-cfemail="1c576e756f687972325e736b6f74796e5c7a787d3274746f327b736a">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the brain stimulation programming
planning software as class II (special controls), which we have
determined will provide a reasonable assurance of safety and
effectiveness. In addition, we believe this action will enhance
patients' access to beneficial innovation, in part by placing the
device into a lower device class than the automatic class III
assignment.
The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an
[[Page 750]]
action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)).
We refer to these devices as ``postamendments devices'' because they
were not in commercial distribution prior to the date of enactment of
the Medical Device Amendments of 1976, which amended the Federal Food,
Drug, and Cosmetic Act (FD&C Act).
FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (see 21 U.S.C. 360c(i)) to a predicate device
that does not require premarket approval. We determine whether a new
device is substantially equivalent to a predicate device by means of
the procedures for premarket notification under section 510(k) of the
FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 (Pub. L. 105-115) established the first procedure for De
Novo classification. Section 607 of the Food and Drug Administration
Safety and Innovation Act (Pub. L. 112-144) modified the De Novo
application process by adding a second procedure. A device sponsor may
utilize either procedure for De Novo classification.
Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
Under either procedure for De Novo classification, FDA is required
to classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
When FDA classifies a device into class I or II via the De Novo
process, the device can serve as a predicate for future devices of that
type, including for 510(k)s (see section 513(f)(2)(B)(i) of the FD&C
Act). As a result, other device sponsors do not have to submit a De
Novo request or premarket approval application to market a
substantially equivalent device (see section 513(i) of the FD&C Act,
defining ``substantial equivalence''). Instead, sponsors can use the
less-burdensome 510(k) process, when necessary, to market their device.
II. De Novo Classification
On February 3, 2021, FDA received Medtronic Neuromodulation's
request for De Novo classification of the SureTune4 Software. FDA
reviewed the request in order to classify the device under the criteria
for classification set forth in section 513(a)(1) of the FD&C Act.
We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the
information submitted in the request, we determined that the device can
be classified into class II with the establishment of special controls.
FDA has determined that these special controls, in addition to the
general controls, will provide reasonable assurance of the safety and
effectiveness of the device.
Therefore, on August 23, 2021, FDA issued an order to the requester
classifying the device into class II. In this final order, FDA is
codifying the classification of the device by adding 21 CFR
882.5855.\1\ We have named the generic type of device brain stimulation
programming planning software, and it is identified as a prescription
device intended to assist in planning stimulation programming for
implanted brain stimulators.
---------------------------------------------------------------------------
\1\ FDA notes that the ``ACTION'' caption for this final order
is styled as ``Final amendment; final order,'' rather than ``Final
order.'' Beginning in December 2019, this editorial change was made
to indicate that the document ``amends'' the Code of Federal
Regulations. The change was made in accordance with the Office of
Federal Register's (OFR) interpretations of the Federal Register Act
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and
parts 21 and 22), and the Document Drafting Handbook.
---------------------------------------------------------------------------
FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.
Table 1--Brain Stimulation Programming Planning Software Risks and
Mitigation Measures
------------------------------------------------------------------------
Identified risks Mitigation measures
------------------------------------------------------------------------
Suboptimal stimulation settings leading Software verification,
to temporary injury or impairment and/ validation, and hazard
or ineffective stimulation. analysis; Usability
assessment; and Labeling.
------------------------------------------------------------------------
FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. For a device to fall within this
classification, and thus avoid automatic classification in class III,
it would have to comply with the special controls named in this final
order. The necessary special controls appear in the regulation codified
by this order. This device is subject to premarket notification
requirements under section 510(k) of the FD&C Act.
At the time of classification, brain stimulation programming
planning software is for prescription use only. Prescription devices
are exempt from the requirement for adequate directions for use for the
layperson under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1))
and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met.
III. Analysis of Environmental Impact
The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
IV. Paperwork Reduction Act of 1995
This final order establishes special controls that refer to
previously
[[Page 751]]
approved collections of information found in other FDA regulations and
guidance. These collections of information are subject to review by the
Office of Management and Budget (OMB) under the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501-3521). The collections of information in 21 CFR
part 860, subpart D, regarding De Novo classification have been
approved under OMB control number 0910-0844; the collections of
information in 21 CFR part 814, subparts A through E, regarding
premarket approval, have been approved under OMB control number 0910-
0231; the collections of information in part 807, subpart E, regarding
premarket notification submissions, have been approved under OMB
control number 0910-0120; the collections of information in 21 CFR part
820, regarding quality system regulation, have been approved under OMB
control number 0910-0073; and the collections of information in 21 CFR
parts 801and 809, regarding labeling, have been approved under OMB
control number 0910-0485.
List of Subjects in 21 CFR Part 882
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
882 is 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. Add Sec. 882.5855 to subpart F to read as follows:
Sec. 882.5855 Brain stimulation programming planning software.
(a) Identification. The brain stimulation programming planning
software is a prescription device intended to assist in planning
stimulation programming for implanted brain stimulators.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Software verification, validation, and hazard analysis must be
performed.
(2) Usability assessment must demonstrate that the intended user(s)
can safely and correctly use the device.
(3) Labeling must include:
(i) The implanted brain stimulators for which the device is
compatible.
(ii) Instructions for use.
(iii) Instructions and explanations of all user-interface
components.
(iv) A warning regarding use of the data with respect to not
replacing clinical judgment.
Dated: December 28, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-28603 Filed 1-4-23; 8:45 am]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on January 5, 2023.
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.