Rule2026-07366
Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators
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
April 16, 2026
Effective
May 18, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is issuing a final order to reclassify non-invasive bone growth stimulators (product codes LOF and LPQ), postamendments class III devices, into class II, subject to premarket notification. FDA is codifying the reclassification of these devices under the new classification regulation, "non-invasive bone growth stimulator." FDA is also establishing the special controls necessary to provide reasonable assurance of safety and effectiveness of these devices.
Full Text
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<title>Federal Register, Volume 91 Issue 73 (Thursday, April 16, 2026)</title>
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[Federal Register Volume 91, Number 73 (Thursday, April 16, 2026)]
[Rules and Regulations]
[Pages 20352-20362]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-07366]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 890
[Docket No. FDA-2020-N-1053]
Physical Medicine Devices; Reclassification of Non-Invasive Bone
Growth Stimulators
AGENCY: Food and Drug Administration, HHS.
ACTION: Final amendment; final order.
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SUMMARY: The Food and Drug Administration (FDA) is issuing a final
order to reclassify non-invasive bone growth stimulators (product codes
LOF and LPQ), postamendments class III devices, into class II, subject
to premarket notification. FDA is codifying the reclassification of
these devices under the new classification regulation, ``non-invasive
bone growth stimulator.'' FDA is also establishing the special controls
necessary to provide reasonable assurance of safety and effectiveness
of these devices.
DATES: This order is effective May 18, 2026.
ADDRESSES: For access to the docket to read background documents or
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 final rule 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: John Gomes, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4564, Silver Spring, MD 20993, 301-796-5618,
<a href="/cdn-cgi/l/email-protection#63290c0b0d4d240c0e0610230507024d0b0b104d040c15"><span class="__cf_email__" data-cfemail="ace6c3c4c282ebc3c1c9dfeccac8cd82c4c4df82cbc3da">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended,
establishes a comprehensive system for the regulation of medical
devices intended for human use. Section 513 of the FD&C Act (21 U.S.C.
360c) established three classes of devices, reflecting the regulatory
controls needed to provide reasonable assurance of their safety and
effectiveness. The three classes of devices are class I (general
controls), class II (special controls), and class III (premarket
approval).
Devices that were not introduced or delivered for introduction into
interstate commerce for commercial distribution prior to May 28, 1976
(generally referred to as postamendments devices) are automatically
classified by section 513(f)(1) of the FD&C Act into class III without
any FDA rulemaking process. Those devices remain in class III and
require premarket approval, unless and until (1) the Food and Drug
Administration (FDA, the Agency, or we) reclassifies the device into
class I or II; or (2) FDA issues an order finding the device to be
substantially equivalent, in accordance with section 513(i) of the FD&C
Act, to a predicate device that does not require premarket approval.
FDA determines whether new devices are substantially equivalent to
predicate devices using the procedures in section 510(k) of the FD&C
Act (21 U.S.C. 360(k)) and our implementing regulations (21 CFR part
807, subpart E).
A postamendments device that has been initially classified into
class III under section 513(f)(1) of the FD&C Act may be reclassified
into class I or II under section 513(f)(3) of the FD&C Act, which
provides that FDA, acting by administrative order, can reclassify the
device into class I or II on its own initiative, or in response to a
petition from the manufacturer or importer of the device. To change the
classification of the device, the new class must have sufficient
regulatory controls to provide reasonable assurance of safety and
effectiveness of the device for its intended use.
FDA relies upon ``valid scientific evidence,'' as defined in
section 513(a)(3) of the FD&C Act and 21 CFR 860.7(c)(2), in the
classification process to determine the level of regulation for
devices. In general, to be considered in the reclassification process,
the ``valid scientific evidence'' upon which the Agency relies must be
publicly available and excludes trade secret and/or confidential
commercial information, such as the contents of a pending premarket
approval application (PMA) (see section 520(c) of the FD&C Act (21
U.S.C. 360j(c)). Section 520(h)(4) of the FD&C Act (the ``six-year
rule'') provides that FDA may use, for reclassification of a device,
certain information in a PMA 6 years after the application has been
approved. This includes information from clinical and preclinical tests
or studies that demonstrate the safety and effectiveness of the device,
but it does not include descriptions of methods of manufacture and
product composition and other trade secrets.
Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the requirements under section 510(k) of the FD&C Act if
FDA determines that a premarket notification (510(k)) is not necessary
to provide reasonable assurance of the safety and effectiveness of the
device.
On August 17, 2020, FDA published in the Federal Register a
proposed order \1\ to reclassify non-invasive bone growth stimulators
intended to promote osteogenesis as an adjunct to primary treatments
for fracture fixation and spinal fusion or as a treatment for
established nonunions or failed fusions \2\ (product codes LOF and LPQ)
<SUP>3 4</SUP> from class III into class II,
[[Page 20353]]
subject to premarket notification (85 FR 49986 (August 17, 2020), the
``proposed order''). FDA has considered the information available to
the Agency, including certain information in PMAs in accordance with
the six-year rule,\5\ peer-reviewed literature, the deliberations of
the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices
Advisory Committee convened on September 8-9, 2020 (the ``Panel'') to
discuss non-invasive bone growth stimulators and the proposed
reclassification (as discussed in section II of this final order), as
well as comments from the public docket on the proposed order (as
discussed in section III of this final order), to determine whether
there is sufficient information to establish special controls to
effectively mitigate the risks to health (updated, as discussed in
section IV of this final order). FDA has also determined based on this
information that the special controls, together with general controls,
provide a reasonable assurance of safety and effectiveness when applied
to these devices.
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\1\ FDA notes that the ``ACTION'' caption for the proposed order
was styled as ``Proposed amendment; proposed order; request for
comments,'' rather than ``Proposed 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.
\2\ The intended use language adopted in this final order adds
``or as a treatment for established nonunions or failed fusions'' to
the original intended use language presented in section III of the
proposed order (85 FR 49986 at 49989).
\3\ FDA's Center for Devices and Radiological Health (CDRH) uses
product codes to help categorize and ensure consistent regulation of
medical devices. A product code consists of three characters that
are assigned at the time a product code is generated and is unique
to a product type. The three characters carry no other significance
and are not an abbreviation.
\4\ Invasive bone growth stimulators, designated under product
code LOE, are outside the scope of this reclassification final
order.
\5\ In support of this reclassification, FDA, on its own
initiative, relied on certain data from relevant original PMAs and
relevant PMA panel-track supplements, available to FDA with product
code of LOF, in accordance with the six-year rule (see section
520(h)(4) of the FD&C Act (21 U.S.C. 360j(h)(4))) (See also, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-section-216-food-and-drug-administration-modernization-act-1997-guidance-industry-and-fda">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-section-216-food-and-drug-administration-modernization-act-1997-guidance-industry-and-fda</a>). This includes data from relevant
original PMAs and relevant PMA panel-track supplements approved
after November 28, 1990, and before Jan 1, 2020, as noted in section
VII of the proposed order (85 FR 49986 at 49990). FDA's PMA database
can be found at <a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm">https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm</a>. For the purpose of this final order, PMA data
considered in accordance with section 520(h)(4) include only that
data which was submitted to and therefore considered by FDA at the
time the PMA was reviewed and approval was issued.
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Therefore, in accordance with section 513(f)(3) of the FD&C Act,
FDA, on its own initiative, is issuing this final order \6\ to
reclassify non-invasive bone growth stimulators intended to promote
osteogenesis as an adjunct to primary treatments for fracture fixation
and spinal fusion or as a treatment for established nonunions or failed
fusions from class III to class II (special controls). Absent the
special controls identified in this final order, general controls
applicable to the device type are insufficient to effectively mitigate
the risks identified for this device type, and therefore insufficient
to provide reasonable assurance of the safety and effectiveness of
these devices.
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\6\ FDA notes that the ``ACTION'' caption for this final order
is styled as ``Final amendment; final order,'' rather than ``Final
order.'' (See footnote 1 for explanation of editorial change.)
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For these class II devices, instead of a PMA, manufacturers may
submit a premarket notification and obtain FDA clearance of the devices
before marketing them. This action will decrease regulatory burden on
industry, as manufacturers will no longer have to submit a PMA for
these types of devices but can instead submit a 510(k) to the Agency
for clearance prior to marketing their device. A 510(k) typically
results in a shorter premarket review timeline compared to a PMA, which
ultimately provides patients with more timely access to these types of
devices. FDA expects that the reclassification of these devices would
enable more manufacturers to develop these types of devices such that
patients will benefit from increased access to non-invasive bone growth
stimulators for which there is a reasonable assurance of safety and
effectiveness.
II. Deliberations of the Panel Meeting
A. Summary of Panel Discussion
On September 8, 2020, the Panel met to discuss and make
recommendations regarding the proposed reclassification of non-invasive
bone growth stimulators from class III into class II (Ref. 1). At the
Panel meeting, FDA presented the regulatory history,\7\ risks to
health, mitigations, and special controls described in the proposed
order (85 FR 49986).
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\7\ The regulatory history of these devices includes significant
action around a 2005 petition for reclassification that was referred
to the Orthopaedic and Rehabilitation Devices Panel of the Medical
Devices Advisory Committee. In 2006, that panel met to consider the
petition and its recommendations were published in the Federal
Register on January 17, 2007 (72 FR 1951). The petitioner
subsequently withdrew their petition and the action was closed. In
2015, FDA identified non-invasive bone growth stimulators as a
potential candidate for reclassification (80 FR 23798) and
subsequently proposed to reclassify these devices by administrative
order on its own initiative, taking into account the regulatory
history of the device type (85 FR 49986).
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The Panel generally agreed with the risks to health identified by
FDA and provided recommendations to better qualify and define some of
the risks to health, as discussed in section II.B of this final order.
The Panel unanimously agreed that general controls alone are not
sufficient to provide a reasonable assurance of safety and
effectiveness for non-invasive bone growth stimulators. The Panel also
unanimously agreed that non-invasive bone growth stimulators are not
life-supporting or life-sustaining. The Panel generally agreed with FDA
that these devices are not of substantial importance in preventing
impairment of human health, though one Panel member disagreed on the
grounds that if the device failed to work as intended to treat an
established nonunion, that failure may have significant health impacts
rising to the level of substantial importance in preventing impairment
of human health. The Panel unanimously agreed that non-invasive bone
growth stimulators do not present a potential unreasonable risk of
illness or injury.
The Panel unanimously agreed that sufficient information exists to
develop special controls for these devices. The Panel deliberated on
whether the special controls proposed by FDA appropriately mitigate the
identified risks to health for this device type, and whether additional
or different special controls should be considered. The Panel generally
agreed with FDA's proposed special controls and recommended additional
special controls. The Panel recommended that the special controls
include specific requirements to ensure a rigorous clinical data set
and postmarket surveillance as a means of assessing longer-term
performance. The Panel also recommended that the special controls
include measures beyond labeling to address risks related to
interference with other electronic devices.
In conclusion, while the Panel recommended revisions to the risks
to health and additional special controls (as discussed in section II.B
of this final order), it generally agreed that non-invasive bone growth
stimulators met each of the criteria that would support FDA's proposed
reclassification of these devices from class III into class II, subject
to premarket notification and special controls to mitigate the
identified risks to health for these devices.
B. FDA Responses to Panel Deliberations and Changes in the Final Order
FDA considered the Panel's comments and recommendations and, as
described below, either modified the final order in response to Panel
feedback or explained why we disagreed with the Panel.
1. Risks to Health
The Panel recommended that FDA clarify the risk of adverse
interactions with other devices and include additional mitigation
measures for these risks beyond labeling. Accordingly, FDA
[[Page 20354]]
reevaluated the risks to health and mitigation measures for adverse
interaction with internal/external fixation devices and electromagnetic
interference (EMI). FDA made minor revisions in section IV of this
final order to clarify in the identified risks that tissue damage is a
result of heating of the fixation device which, in turn, leads to
heating (damage) of the tissue. FDA also reconsidered mitigations for
this risk to health and concluded that thermal safety is an important
consideration, as signal outputs could induce currents in metal
implants (for modalities that employ electromagnetic fields) or could
cause deep tissue heating (for ultrasound-based devices). We therefore
revised the mitigation measures for this risk in section IV of this
final order to include non-clinical performance testing, which would
include an evaluation of thermal safety and thermal reliability. FDA
also revised relevant parts of the non-clinical performance testing
special control at 21 CFR 890.5870(b)(2) to clarify that thermal safety
and thermal reliability must be verified and validated. This could be
demonstrated through non-clinical performance testing, for example,
using applicable consensus standards (e.g., IEC 60601 series of
standards for the basic safety and essential performance of medical
electrical equipment), or other validated methods.
In addition, we revised the EMI risk in section IV of this final
order to clarify that patient harms could result from interference
between non-invasive bone growth stimulators and electrically powered
implanted devices (i.e., non-invasive bone growth stimulators may
interfere with implanted devices and vice versa), and also due to
interference from electronically powered devices in the environment
(such as radio-frequency emitting household electrical equipment).
While implanted electrical devices (e.g., pacemakers or nerve
stimulators) may have been designed to have immunity to certain
electromagnetic fields, there is potential for the electromagnetic
fields of non-invasive bone growth stimulators to interfere with
implanted devices, or for the electromagnetic fields of implanted
devices to cause electromagnetic interference with non-invasive bone
growth stimulators. Furthermore, internal/external fixation devices in
the proximity of non-invasive bone growth stimulators may similarly
interfere with the treatment signal or lead to heating of the fixation
device, which could lead to heating and damage of the surrounding
tissue. We believe the mitigation measures (electromagnetic
compatibility (EMC) testing and labeling) address these risks, and that
no further revisions to the mitigation measures for the EMI risk are
necessary. As a potential method of EMC testing to mitigate EMI risks,
FDA suggests using FDA-recognized consensus standards \8\ for medical
electrical equipment safety and electromagnetic compatibility,
including IEC 60601-1-2 Medical electrical equipment--Part 1-2: General
requirements for basic safety and essential performance--Collateral
Standard: Electromagnetic disturbances--Requirements and tests (Ref.
2). Additional collateral standards within the IEC 60601 series of
standards may also apply, depending on the technology used in the
device. Additionally, the labeling special control requires appropriate
warnings for patients with implantable devices. Consistent with
aforementioned consensus standards, such warnings in the labeling
should specify appropriate separation distances, when applicable.
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\8\ FDA recognizes certain voluntary consensus standards for
medical devices, which are identified in a database available at
<a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm">https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm</a>.
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The Panel recommended that the risk of adverse biological effects
either be better defined or otherwise removed from the list of risks to
health associated with non-invasive bone growth stimulators. FDA
maintains that this risk should be included, given that signals with
select characteristics could induce adverse biologic effects outside of
thermal risks. We have revised the description of this risk to health
in section IV of this final order to address the Panel's recommendation
and list the signal characteristics that may lead to adverse biologic
effects.
During the Panel's discussion of the risks to health, the Panel
Chair summarized an additional concern as ``if the signal
characteristics themselves need to be defined in a way that
characterized safety and efficacy in a way that was independent from
the field characteristics'' (Ref. 3 at lines 3135-37). FDA does not
believe any changes beyond those already detailed in this section are
necessary to address this concern. The Panel did not identify a
specific risk to health, and the stated concerns are already captured
in the risks identified in section IV of this final order such as
failure or delay of osteogenesis, adverse interaction with internal/
external fixation devices, adverse biologic effects, and burn.
2. Criteria for Classification
Most of the Panel agreed that non-invasive bone growth stimulators
met the criteria for classification into class II. The Panel
unanimously agreed that general controls alone are not sufficient to
provide reasonable assurance of safety and effectiveness, that non-
invasive bone growth stimulators do not present a potential
unreasonable risk of illness or injury, and that sufficient information
exists to establish special controls for non-invasive bone growth
stimulators. All but one Panel member agreed that non-invasive bone
growth stimulators are not ``life-supporting or life-sustaining, or of
substantial importance in preventing impairment of human health.'' This
Panel member disagreed on the grounds that if the device failed to work
as intended to treat an established nonunion, that failure may have
significant health impacts rising to the level of substantial
importance in preventing impairment of human health. Other Panel
members responded with the view that the impairment was the nonunion
and a failure to heal the nonunion was not itself the cause of the
nonunion. We additionally note that FDA identified (and the Panel
concurred) that failed or delayed osteogenesis is a risk for this
device, but measures such as clinical and non-clinical performance
testing would mitigate the risk of failed or delayed osteogenesis and
provide a reasonable expectation of the effectiveness of various
treatment uses. FDA agrees with the majority of the Panel that this
device type meets all of the criteria for regulation as a class II
device.
3. Special Controls
The Panel recommended adding a special control for postmarket
surveillance to monitor device effectiveness in real-world clinical
practice. FDA disagrees. Postmarket surveillance as described by the
Panel is not necessary to demonstrate reasonable assurance of safety
and effectiveness. The safety profile of non-invasive bone growth
stimulators is based on a long history of use of these devices and
supports FDA's position that these devices do not pose sufficient
safety concerns to warrant postmarket surveillance beyond standard
postmarket requirements (i.e., medical device reporting (MDR)
requirements). Consistent with this safety profile, none of the non-
invasive bone growth stimulator devices currently on the market under
an approved PMA has required or relied on post-approval studies.
Additionally, FDA's clinical
[[Page 20355]]
data special control will help ensure there is sufficient evidence that
the device performs as intended without the need to rely upon
postmarket data for this determination.
The Panel additionally recommended that the clinical data special
control include specific requirements to ensure a rigorous data set,
such as specifying imaging modalities and a follow-up study of at least
one year to confirm that the device is effective for its intended use.
As discussed in more detail in our response to comment 2 in section III
of this final order, the clinical data special control sets the
expectation that manufacturers will provide robust clinical data to
demonstrate that the device performs as intended under the anticipated
conditions of use. FDA disagrees that it is necessary to specify
prescriptive imaging modalities or the length of follow-up for a
premarket clinical study. Appropriate timeframes for follow-up studies
depend on the type of fracture and anatomic site being treated, as the
timeframes to achieve fusion may vary. As such, the special control for
clinical performance data has been purposefully written in a way to
allow for flexibility in the endpoints and measures used to demonstrate
patient benefits and mitigation of risks for this device type. However,
to help ensure that clinical data meets appropriate fusion endpoints
for the device's intended use, we added a requirement in the clinical
data special control at 21 CFR 890.5870(b)(1) that ``[i]maging data
must demonstrate fusion at the treatment site.''
III. Comments on the Proposed Order
A. Introduction
FDA received comments from fewer than 10 commenters on the proposed
order (85 FR 49986) published in the Federal Register on August 17,
2020. The comment period on the proposed order closed on October 16,
2020. Comments received by the close of the comment period were from
Congressional representatives, a trade organization, an orthopaedic
scientist-surgeon, and other interested parties. Some of the comments
contained one or more comments on one or more issues. Some comments
supported the proposed reclassification, and others recommended against
reclassification. Various comments included recommendations for special
controls that commenters believed were necessary to establish
reasonable assurance of safety and effectiveness.
We describe and respond to the comments in section III.B of this
final order. The order of the comments and responses is purely for
organizational purposes and does not signify the comment's value or
importance nor the order in which comments were received. To provide
organized and efficient responses to similar issues, we grouped
comments by similar subject matter, and, in some cases, we treated
different subjects presented by the same commenter as distinct
comments.
B. Description of Comments and FDA Response
(Comment 1) Various commenters agreed with the proposal to
reclassify non-invasive bone growth stimulators into class II. These
comments generally spoke to the importance of patient access and the
relatively low risk of these devices. They also stated that a lower
classification (i.e., class II instead of class III) could expedite
bringing new non-invasive bone growth stimulators to market. Two
comments, representing multiple interested parties, disagreed with FDA,
asserting that non-invasive bone growth stimulators should be retained
in class III because class II controls are insufficient to provide
reasonable assurance of safety and effectiveness.
(Response 1) FDA agrees with the comments supporting
reclassification of non-invasive bone growth stimulators into class II
and disagrees that these devices should be retained in class III. Based
on publicly available scientific evidence presented in the proposed
order and to the Panel, and taking into consideration feedback from the
Panel and comments received on the proposed order, FDA has determined
that reclassification of non-invasive bone growth stimulators into
class II, subject to premarket notification, is appropriate because
general controls by themselves are insufficient to provide reasonable
assurance of safety and effectiveness and there is sufficient
information to establish special controls to provide such assurance.
The Panel also unanimously agreed that non-invasive bone growth
stimulators met the criteria for classification into class II.
Additionally, class III is inappropriate because FDA has
determined, and a large majority of the Panel agreed, that non-invasive
bone growth stimulators are not for use in supporting or sustaining
human life, are not of substantial importance in preventing impairment
of human health, and do not present a potential unreasonable risk of
illness or injury.
We also agree with commenters that this reclassification may have a
positive impact on bringing new non-invasive bone growth stimulators to
market more quickly. As discussed in section I of this final order,
reclassifying non-invasive bone growth stimulators into class II will
reduce regulatory burdens on industry because instead of submitting a
PMA, manufacturers may submit a less burdensome 510(k) to obtain FDA
clearance of the device before marketing it, among other lesser
regulatory requirements. We expect that this would, in turn, increase
access to safe and effective therapeutics for which there is still a
reasonable assurance of safety and effectiveness. The 510(k) pathway is
less burdensome and generally more cost-effective for industry and FDA
than the PMA pathway, the most stringent type of device marketing
application required by FDA. A 510(k) typically results in a shorter
premarket review timeline compared to a PMA, which ultimately provides
more timely access of these types of devices to patients.
(Comment 2) A couple commenters provided recommendations regarding
the quality of clinical performance data that FDA should require to
support future marketing submissions for non-invasive bone growth
stimulators. One commenter suggested that special controls should
require high-quality clinical data without commenting on whether non-
invasive bone growth stimulators should be reclassified. Another
commenter stated that non-invasive bone growth stimulators should
remain a class III device, but if FDA proceeds with reclassification,
certain data quality standards should apply. These commenters
emphasized the importance of prospective, randomized clinical trials to
ensure these submissions include robust clinical evidence. One
commenter additionally recommended that future clinical studies employ
similar clinical trial design parameters as those used in pivotal
studies for currently approved non-invasive bone growth stimulators,
using clinically relevant endpoints based on imaging data and clinical
measures of a subject's healing or functioning. The commenter also
specified that the clinical data should be derived from clinical trials
rather than citation of published literature.
(Response 2) While FDA agrees that high-quality clinical data is
necessary to support 510(k)s for non-invasive bone growth stimulators,
FDA disagrees that the clinical data special control should
specifically require prospective, randomized clinical trials to
demonstrate the effectiveness of new devices brought to the market. FDA
also agrees that imaging data should be required to demonstrate device
effectiveness and we have revised the clinical data special control
accordingly,
[[Page 20356]]
as further described in section II.B.3 of this final order.
We also note that data supporting approved PMAs for non-invasive
bone growth stimulators were based on a range of sources that did not
always include prospective randomized clinical trials. While a
randomized, controlled clinical study is the highest standard for data
quality, there are many sources of robust, quality clinical data that
meet FDA standards for ``valid scientific evidence'' (21 CFR 860.7),
including non-randomized studies compared to registry data, or other
sources of real-world evidence. Therefore, the special controls we are
finalizing for non-invasive bone growth stimulators are intentionally
flexible and purposefully not intended to limit the types of clinical
evidence that may support a 510(k) for these devices.
As discussed in the proposed order, differences in treatment
waveform and frequency can have unknown effects on the healing pathway,
resulting in significant effects on reported device effectiveness (85
FR 49986 at 49991). Therefore, to demonstrate substantial equivalence,
clinical performance data must demonstrate that the device performs as
intended in the indicated patient population. FDA recommends that the
clinical study be sufficiently robust to adequately support the
proposed indications for use for the device. A randomized prospective
clinical trial would suffice, however, in certain circumstances, other
forms of clinical evidence, such as real-world evidence, would also be
adequately robust to support a substantial equivalence determination.
Such data should be scientifically valid and include sufficient
information to demonstrate a clinically meaningful benefit of the
device and describe the expected safety profile, as defined in section
513(a)(3) of the FD&C Act and 21 CFR 860.7(c)(2).
Additionally, to demonstrate that the device performs as intended
under anticipated conditions of use, the data should represent the
intended patient population and intended anatomic location of the
device. The study should include appropriate, clinically relevant
endpoints. While the endpoint will depend on the device's specific
indications for use, independent radiographic assessment of bone fusion
using a clinically recognized scale and validated assessments of
clinical healing are examples of appropriate endpoints. To support a
demonstration of substantial equivalence, the study should also include
sufficient evidence that the device performs equivalently to a legally
marketed predicate device. If the subject device is not studied in
conjunction with the predicate device, we recommend that the study
design demonstrate a clinically meaningful and statistically
significant improvement compared to an appropriate control (e.g., sham
device). A side-by-side study could also be used to demonstrate
substantial equivalence in clinically relevant endpoints (e.g., time to
radiographic and clinical healing) between the subject device and a
legally marketed predicate.
In lieu of using new clinical data to support a 510(k), applicants
may be able to rely on clinical data from a legally marketed non-
invasive bone growth stimulator with the same intended use and
indications for use, if the applicant demonstrates that the critical
signal parameters and operational modality of their device are
sufficiently similar to those of the legally marketed device. This
approach is consistent with leveraging publicly available data to
support approval of a PMA.\9\ Further, we revised the labeling special
control in this final order to require ``a detailed summary of the
supporting clinical data'' rather than ``a detailed summary of the
clinical testing'' as initially proposed to more accurately represent
the sources of data that may be relied upon for a 510(k). As stated
above, if the applicant demonstrates that the critical signal
parameters of their device are sufficiently similar to those of a
legally marketed predicate device, then the ``supporting clinical
data'' may include clinical data sets generated using that predicate
device.\10\
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\9\ Examples of approved PMAs for non-invasive bone growth
stimulators that have leveraged publicly available clinical data in
their submissions since December 2020, in accordance with the 6-year
rule (see section 520(h)(4) of the FD&C Act), include P190030,
P210035, P230025, P210016 (Refs. 4-7). While the 6-year rule applies
only to PMAs, 510(k)s may be able to leverage clinical information
and data from a sufficiently similar predicate device, assuming the
sponsor has proper access to such data.
\10\ Under 21 CFR 807.92(b)(2), when the determination of
substantial equivalence is based in part on an assessment of
clinical performance data, the summary should include a brief
discussion of the clinical tests submitted, referenced, or relied on
in the premarket notification submission for a determination of
substantial equivalence. This discussion shall include, where
applicable, a description of the subjects upon whom the device was
tested, a discussion of the safety or effectiveness data obtained
from the testing, with specific reference to adverse effects and
complications, and any other information from the clinical testing
relevant to a determination of substantial equivalence.
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The special controls for non-invasive bone growth stimulators
include controls for clinical data and non-clinical performance testing
that could support unique study designs that are appropriate for the
specific indications for use and technological characteristics for each
device that would be reviewed in a 510(k).\11\ While every clinical
study developed to support a premarket submission for non-invasive bone
growth stimulators should be designed to demonstrate that the device
performs as intended when used in the intended patient population, the
final special controls for these devices allow for customized study
designs tailored specifically for each device considering the device
technology and indications for use. Reclassification of these devices
from class III into class II does not exclude the need for device-
specific clinical data and non-clinical performance testing. Rather,
the special controls establish requirements for such data and testing
that is necessary to support reasonable assurance of safety and
effectiveness.
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\11\ A manufacturer may seek FDA input on non-clinical or
clinical study design by utilizing our Q-Submission program, through
which FDA may provide input on device-specific requirements and
recommendations for non-clinical and clinical studies intended to
support device-specific indications for use. Additional information
regarding the Q-Submission program can be found in FDA's final
guidance document entitled ``Requests for Feedback and Meetings for
Medical Device Submissions: The Q-Submission Program'' (Ref. 8). In
addition, reclassification does not change the regulatory
requirements related to clinical study oversight and investigational
device exemptions (IDEs) in 21 CFR part 812 or patient protections
in 21 CFR part 50 and 56. FDA may provide specific feedback and
study design considerations for clinical studies as a part of an IDE
review for significant risk studies.
---------------------------------------------------------------------------
This flexibility is also important for non-clinical performance
testing special control requirements, which include validation and
verification of thermal safety and thermal reliability, that signal
characteristics are within safe physiologic limits, and that device
reliability is consistent with the expected use-life. An applicant may
validate and verify these safety and performance characteristics in a
variety of ways, as discussed in the following paragraphs. Note that
the non-clinical performance testing special control also requires
validation and verification of critical performance characteristics,
which we discuss in our response to comment 4 in this section of the
final order.
Given the potential for devices of this type to cause patient harm
due to heating from multiple sources, the non-clinical special control
requires validation and verification of thermal safety and thermal
reliability. First, as the control units are often worn on a patient's
belt and are battery powered, excessive heating of the control unit for
prolonged duration may cause thermal damage to the patient's skin and
[[Page 20357]]
subdermal tissue. Second, the transducer itself may heat up during use,
causing similar injury at the treatment site if it is patient-
contacting. Finally, the signal itself may cause heating of deep
tissue. This could be due to the electromagnetic fields generated by
pulsed electromagnetic field (PEMF) and combined magnetic field (CMF)
devices inducing currents in nearby metal implants, current leaks in
capacitive coupling (CC) devices causing electrical burns, or low
intensity pulsed ultrasound (LIPUS) devices causing deep tissue heating
due to the mechanical effects of ultrasound signals. Testing results to
appropriate standards (if applicable) to demonstrate that the device
does not cause unsafe heating should be included in support of a
510(k). Literature or other scientific evidence can also be used to
support the generally accepted thermal safety of the subject device's
treatment signal.
Validation and verification that signal characteristics are within
safe physiologic limits is required to mitigate the potential for
patient harm from the generated signal, which could be due to various
factors such as ultrasonic heating or tissue cavitation, excessive
electrical current which could damage tissue, or electromagnetic fields
which may interfere with biological function. Applicants should provide
signal characterization to evaluate the nature of their device and
provide scientific evidence and rationale demonstrating that the device
generates a physiologically safe signal, which may include non-clinical
animal testing,\12\ side-by-side bench testing to demonstrate that the
device signal falls within the range of a predicate device, or
literature to demonstrate that similar signals have a history of safe
use.
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\12\ FDA supports the principles of the ``3Rs,'' to replace,
reduce, and/or refine animal use in testing when feasible. We
encourage sponsors to consult with us if they wish to use a non-
animal testing method they believe is suitable, adequate, validated,
and feasible.
---------------------------------------------------------------------------
Validation and verification that device reliability is consistent
with the expected use-life of the device is required because these
devices are generally used daily by patients for several months and may
be exposed to a large amount of physical wear. A 510(k) should provide
evidence that the device can perform within specifications throughout
its labeled use-life. One form this evidence may take is simulated use
testing of the device. Considerations for the reliability testing
special control (21 CFR 890.5870 (b)(2)(iv)) should include (as
applicable), but not be limited to, continued integrity of all
connection ports, repeated battery connection and disconnection,
battery performance after repeated charging/discharging, integrity of
all buttons/switches, performance of components after repeated
reprocessing, activation of transducer for the full use-life of the
device, and environmental exposure (e.g., humidity).
(Comment 3) One commenter expressed concern that, by publishing the
proposed order in the Federal Register in advance of the Panel meeting,
``FDA has already prejudged the outcome'' of the meeting and would
potentially influence the Panel's recommendations.
(Response 3) FDA complied with all statutory and regulatory
requirements in its proposal to reclassify non-invasive bone growth
stimulators under section 513(f)(3) of the FD&C Act, which allows, but
does not require, FDA to convene a classification panel and does not
prescribe when the panel meeting and proposed order must occur in
relation to each other. In the preamble to the final rule updating
FDA's medical device classification procedures regulations to reflect
updates made to the FD&C Act in 2012 by the Food and Drug
Administration Safety and Innovation Act (FDASIA) (Pub. L. 122-144),
FDA stated its intent to issue a reclassification proposed order under
section 513(f)(3) before holding the classification panel meeting (83
FR 64443 at 64451 (December 17, 2018)). FDA's statement was in response
to comments from interested parties suggesting that Congress intended
this order when they passed FDASIA (83 FR at 64450). Since then, in
cases when FDA has elected to convene a classification panel for a
potential reclassification action under section 513(f)(3) of the FD&C
Act, FDA has generally issued the proposed order before convening the
panel.
(Comment 4) More than one commenter noted the wide range of
technologies that have been approved as non-invasive bone growth
stimulators and expressed concern that class II special controls could
not be established to provide reasonable assurance of safety and
effectiveness for the generic device type at least in part because of
this wide range of technologies.
(Response 4) While we acknowledge that FDA has approved PMAs for
non-invasive bone growth stimulators with an array of different
technologies (e.g., PEMF, CMF, CC, and LIPUS), we disagree that special
controls cannot be established to provide reasonable assurance of
safety and effectiveness. Furthermore, as discussed in section II.A of
this final order, the Panel also unanimously agreed with FDA's
conclusion that sufficient information exists to establish special
controls.
In evaluating whether non-invasive bone growth stimulators should
be reclassified into class II, we considered the risks to health and
risk mitigations associated with the different technologies of approved
devices. As part of this assessment, we evaluated peer-reviewed
literature, MDRs, recalls, and additional information (e.g., the
Summary of Safety and Effectiveness from PMAs subject to the six-year
rule \13\). FDA concluded that the risks to health associated with
approved non-invasive bone growth stimulators, and the appropriate
mitigations of those risks, are the same across all modalities. For
this reason, the special controls provide flexibility while still
requiring manufacturers to account for the critical characteristics of
their particular technology. While the specific testing necessary to
mitigate risks for a particular device may differ by technology, the
special controls are written broadly enough to apply to all non-
invasive bone growth stimulators, regardless of technology.
---------------------------------------------------------------------------
\13\ See footnote 5 for information regarding the PMAs relied on
to support this reclassification.
---------------------------------------------------------------------------
For example, the non-clinical performance data special control (21
CFR 890.5870(b)(2)) requires validation and verification of critical
performance characteristics to ensure that intended design outputs are
delivered to the patient. This particular special control is broadly
written to allow for flexibility in terms of which specific design
outputs are relevant based upon the modality of the device. To fully
describe the specific device and allow for a comparison to the
predicate, we suggest providing a full and complete characterization of
both the device and the therapeutic signal in the 510(k). We recommend
that characterization of the signal waveform include images and a
sufficiently detailed description to ensure continued treatment
effectiveness. Because of the wide range of signal modalities
applicable to non-invasive bone growth stimulators (e.g., PEMF, CMF,
CC, and LIPUS), it is not possible to list every treatment signal
parameter that should be assessed; however, in general, we recommend
including the following (as applicable): output signal shape,
magnitude, primary frequency, carrier frequency, duty cycle, focal
depth, magnetic flux, effective radiating area, total average power,
spatial average-temporal average intensity, beam non-uniformity ratio,
and any other measure needed to fully characterize the treatment
signal.
[[Page 20358]]
Additionally, different treatment signals will pass through human
tissue and bone in different ways. Consequently, while the device may
be generating a treatment signal of a specific amplitude or waveform,
the treatment site may be receiving a different signal. This could be
caused by signal loss from the transducer/air/skin interface, or due to
absorption of signal power or certain frequencies as the signal passes
through soft and hard tissue. Therefore, we recommend applicants
include results from validation testing to assess the signal reaching
the treatment site. While it is not possible to consider every
treatment attenuation scenario, we recommend applicants demonstrate
that the intended treatment parameters are delivered throughout a
sufficient volume to encompass the treatment site in the indicated
patient population. Examples of testing may include measurement of the
signal in an appropriate surrogate (e.g., phantom model).
(Comment 5) One commenter requested that FDA issue a special
controls guidance to outline additional detail regarding ``key
parameters for clinical studies and other data (labeling comprehension
and device usability testing) to support marketing of never before-
authorized [non-invasive] bone growth stimulator devices.''
(Response 5) While we do not intend to issue a guidance document to
accompany the special controls identified in this final order for non-
invasive bone growth stimulators at this time, the preamble to this
final order has recommendations and examples for how manufacturers may
comply with the special controls. In section II.B of this final order,
in response to Panel feedback, we provide examples of recognized
consensus standards for EMC testing that would mitigate EMI risks to
satisfy the performance data special control for EMC. In our responses
to comments 2 and 4 in this section of this final order, we provide
examples of the different types of clinical data, clinical studies, and
non-clinical performance data that could support a 510(k) for non-
invasive bone growth stimulators. FDA reviews the non-clinical and
clinical data and related valid scientific evidence included in a
510(k) to assess substantial equivalence to a legally marketed
predicate device, including, as appropriate, conformance to special
controls.
We have also revised the special controls for non-invasive bone
growth stimulators to provide more detail and clarity on FDA's
expectations for clinical data and non-clinical performance testing.
Additionally, as discussed in section II.B.3 and in our response to
comment 2 in this section of the final order, the clinical data special
control now requires imaging data to further support device
effectiveness. Non-clinical performance testing now more clearly
requires verification and validation of critical performance and safety
characteristics, which we discuss in our responses to comments 2 and 4
in this section of the final order.
(Comment 6) One commenter requested that FDA consider adding a
requirement for human factors testing and/or a labeling comprehension
study to the special controls.
(Response 6) FDA agrees with this comment. Based on literature and
clinical data from other sources, FDA concurs that user compliance with
the instructions for use is a significant factor in the effectiveness
of these devices and maintaining user compliance is a known issue for
these devices. These devices are used by patients, and the instructions
for use should be clear and easy to follow. Additionally, labeling
comprehension testing is currently relied upon to support PMA approvals
of non-invasive bone growth stimulators. As such, we have added a
special control to require labeling comprehension testing.
(Comment 7) One commenter stated that FDA should conduct premarket
clinical and manufacturing inspections for these devices, even if they
are reclassified from class III into class II.
(Response 7) FDA generally does not consider premarket clinical and
manufacturing inspections to be necessary to provide reasonable
assurance of safety and effectiveness for class II devices, including
non-invasive bone growth stimulators. Preapproval inspections conducted
in the context of a PMA approval allow FDA to assess the firm's
capability to design and manufacture the device as claimed in the PMA
and confirm that the firm's Quality Management System is in compliance
with 21 CFR part 820, Quality Management System Regulation. FDA
generally does not conduct similar premarket inspections for class II
devices or when reviewing a 510(k).
Additionally, the hardware of these devices can generally be
characterized with well-established methods and standards. The special
controls identified in this final order establish requirements for
validating both software and hardware components of these devices
premarket, including that testing must verify and validate critical
performance and safety characteristics of the device. The special
controls also establish requirements relating to electromagnetic
compatibility, electrical and thermal safety, biocompatibility, and
software verification, validation, and hazard analysis.
For class II devices, routine and for cause inspections, which may
consider compliance with quality management system requirements
applicable to the manufacturing of the device, allow for appropriate
postmarket oversight. Mechanisms and procedures for reporting safety
concerns, such as MDRs and recalls, also provide additional postmarket
surveillance to help ensure continued safety for marketed devices.
(Comment 8) One commenter requested that FDA either ``retain
control over all postmarket [non-invasive bone growth stimulator]
modifications'' through controls applicable to class III devices, or,
if non-invasive bone growth stimulators are reclassified, that FDA
include recommendations in guidance to explain which device
modifications would be subject to premarket review. The commenter
highlighted the importance of regulatory oversight of postmarket
changes to ensure that device performance is not negatively impacted,
noting that the 2006 Advisory Committee \14\ and FDA previously
recognized that device modifications that change device output may have
unknown impacts on clinical response to treatment.
---------------------------------------------------------------------------
\14\ The commenter is referring to a 2006 meeting of the
Orthopaedic and Rehabilitation Devices Panel of the Medical Devices
Advisory Committee, which considered a petition for reclassification
of non-invasive bone growth stimulators. (See footnote 7 for
additional information and references.)
---------------------------------------------------------------------------
(Response 8) FDA disagrees that the requirements applicable to
modifications of PMA-approved products (i.e., premarket approval or
annual reporting of changes as required for class III devices) are
necessary for this device type. Consistent with 21 CFR 807.81(a)(3), a
new 510(k) is required for any change or modification to a cleared
device that could significantly affect the safety or effectiveness of
the device, or for a major change or modification in intended use.\15\
Changes and modifications that could significantly affect the safety or
effectiveness of the device and may require a new 510(k) for
[[Page 20359]]
a non-invasive bone growth stimulator device include:
---------------------------------------------------------------------------
\15\ In accordance with 21 CFR 807.81(a)(3), a 510(k) is
required for significant changes or modifications to a device
including: (1) those that ``could significantly affect the safety or
effectiveness of the device, e.g., a significant change or
modification in design, material, chemical composition, energy
source, or manufacturing process''; or (2) a ``major change or
modification in the intended use of the device.''
---------------------------------------------------------------------------
<bullet> Modifications of the therapeutic signal or modifications
to the transducer such that there is change to the delivered
therapeutic signal.
<bullet> Changes to the indicated patient population (age range,
anatomic location, fracture or fusion type, etc.).
These examples are not exhaustive. Guidance on when device changes
or modifications may require a new 510(k) can be found in ``Deciding
When to Submit a 510(k) for a Change to an Existing Device'' (Ref. 9)
and ``Deciding When to Submit a 510(k) for a Software Change to an
Existing Device'' (Ref. 10).
Regardless of whether a new 510(k) is necessary, a modified device
must continue to comply with the special controls. Additionally,
manufacturers may wish to use predetermined change control plans
(PCCPs) as a way to implement future modifications to their devices
without needing to submit a new 510(k) for each significant change or
modification \16\ while continuing to provide reasonable assurance of
device safety and effectiveness. \17\ FDA reviews a PCCP as part of a
marketing submission for a device to ensure the continued safety and
effectiveness of the device without necessitating additional marketing
submissions for implementing each modification described in the PCCP.
When used appropriately, PCCPs authorized by FDA are expected to be
least burdensome for manufacturers and FDA.\18\
---------------------------------------------------------------------------
\16\ For the purpose of this final order reference to
``modification'' means a significant change or modification that
would generally require a new premarket notification under 21 CFR
807.81(a)(3).
\17\ Section 3308 of the Food and Drug Omnibus Reform Act of
2022, Title III of Division FF of the Consolidated Appropriations
Act, 2023, Public Law 117-328 (``FDORA''), enacted on December 29,
2022, added section 515C ``Predetermined Change Control Plans for
Devices'' to the FD&C Act. Section 515C has provisions regarding
PCCPs for devices requiring premarket approval or premarket
notification. Under section 515C, supplemental applications (section
515C(a)) and new premarket notifications (section 515C(b)) are not
required for a change to a device that would otherwise require a
premarket approval supplement or new premarket notification if the
change is consistent with a PCCP approved or cleared by FDA.
\18\ Sections 513 and 515 of the FD&C Act. See also, FDA's
guidance ``The Least Burdensome Provisions: Concept and
Principles,'' available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/least-burdensome-provisions-concept-and-principles">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/least-burdensome-provisions-concept-and-principles</a>.
---------------------------------------------------------------------------
IV. Changes in the Final Order
As described in sections II and III of this final order, FDA has
made revisions in this final order in response to Panel feedback and
comments submitted to the public docket on the proposed order (85 FR
49986).
Additionally, as noted in footnote 2, FDA has revised the
identification language from the proposed order to add the phrase ``or
as a treatment for established nonunions or failed fusions'' to the
identification language codified in this final order. (See 21 CFR
890.5780(a)). This language was included in the proposed order as an
indication presented to explain the intended use, but FDA has
determined that for completeness it belongs in the identification
language as part of the intended use. FDA has also moved the clause in
the identification language that notes the device is only for
prescription use from the second sentence of the identification to the
first sentence of the identification. This change was made for
consistency with other device types whose classification regulations
fall into 21 CFR part 890. This change does not have any substantive
effect.
Furthermore, in considering the revisions to the final order, FDA
identified and added two additional risks to health: (i) use error or
improper device use, and (ii) infection. While the labeling special
control in the proposed order included cleaning instructions for
reusable components, we recognize that adding the risk of infection
clarifies the importance of validated cleaning instructions as a
mitigation measure to address this risk to health. Accordingly, we
updated the labeling special control to clarify that cleaning
instructions must be validated. As discussed in our response to comment
6, FDA added a risk of use error or improper device use because user
compliance with the instructions for use is a significant factor in the
effectiveness of these devices and maintaining user compliance is a
known issue for these devices. Accordingly, we added a special control
to require that labeling comprehension testing must demonstrate the
patient can correctly use the device based solely on reading the
instructions for use.
Based in part on Panel feedback and comments on the proposed order,
FDA revised the list of risks to health, the special controls that FDA
determined will mitigate these risks, and Table 1, ``Risks to Health
and Risk Mitigation Measures for Non-Invasive Bone Growth
Stimulators''.
FDA has identified the following risks to health associated with
the use of non-invasive bone growth stimulators:
<bullet> Failure or delay of osteogenesis. A patient could receive
ineffective treatment, contributing to failure or delay of osteogenesis
that may lead to clinical symptoms (e.g., pain) and the need for
surgical interventions. Ineffective treatment could be a result of
various circumstances (e.g., inadequate therapeutic signal output or
device malfunction).
<bullet> Use error or improper device use. Use error or improper
device use may result from a device design that is difficult to operate
and/or labeling that is difficult to comprehend, leading to misuse of
the device resulting in patient harm or ineffective treatment.
<bullet> Burn. A patient or health care professional could be
burned from the use and operation of the device. This could be a result
of various circumstances including device malfunction (e.g., electrical
fault) or misuse of the device (e.g., use while sleeping).
<bullet> Electrical shock. A patient or health care professional
could be shocked from the use and operation of the device. This could
be a result of various circumstances including device malfunction
(e.g., electrical fault) or misuse of the device (e.g., use of
alternating current source during treatment).
<bullet> Electromagnetic interference (EMI). A patient with
electrically powered implanted devices (such as cardiac pacemakers,
cardiac defibrillators, and neurostimulators) could experience harm due
to device malfunction as a result of electromagnetic interference
between the implanted device and the non-invasive bone growth
stimulator. Electronically powered devices in the environment (such as
radiofrequency emitting household electrical equipment), may similarly
interfere with the non-invasive bone growth stimulator device.
<bullet> Adverse tissue reaction. A patient could experience skin
irritation and/or allergic reaction associated with the use and
operation of the device via the use of non-biocompatible device
materials.
<bullet> Infection. A patient could experience an infection if the
patient-contacting components are not properly cleaned between uses.
<bullet> Adverse interaction with internal/external fixation
devices. The signal output could be impacted by certain metallic
internal or external fixation devices leading to inadequate treatment
signals, device malfunction, or tissue heating and damage as a result
of heating of the fixation device.
<bullet> Adverse biologic effects. A patient may experience adverse
biologic effects resulting from prolonged exposure to the treatment
signal via biologic interaction with the treatment signal at a cellular
level. This could be due to various factors such as ultrasonic heating
or tissue cavitation, excessive electrical current which could damage
[[Page 20360]]
tissue, or electromagnetic fields which may interfere with biological
function.
FDA has determined that the following special controls will
mitigate these risks to health, and that these special controls, in
addition to general controls, will provide a reasonable assurance of
safety and effectiveness for non-invasive bone growth stimulators:
<bullet> The risk of failure or delay of osteogenesis can be
mitigated by clinical data that demonstrates that the device performs
as intended under anticipated conditions of use, including imaging data
to demonstrate fusion at the treatment site. This risk can also be
mitigated by non-clinical performance testing which additionally
demonstrates that the device performs as intended under anticipated
conditions of use, specifically through verification and validation of
critical performance characteristics of the device. These include
ensuring delivery of intended design outputs to the patient, thermal
safety and reliability, the signal characteristics are within safe
physiologic limits, and reliability of the device is consistent over
the expected use-life. Software verification, validation, and hazard
analysis will also help mitigate the risk of failure or delay of
osteogenesis by ensuring that any device software performs as intended.
Finally, labeling will also mitigate this risk by providing appropriate
instructions for use (e.g., duration, frequency of use) to the end
user.
<bullet> The risk of use error or improper device use can be
mitigated through labeling, including adequate warnings and
instructions for use, and labeling comprehension testing that
demonstrates the patient can correctly use the device based solely on
reading the instructions for use.
<bullet> The risk of burns can be mitigated by non-clinical
performance testing of the device to verify and validate critical
performance characteristics, which include ensuring thermal safety and
reliability, signal characteristics are within safe physiologic limits,
and reliability of the device is consistent with its expected use-life.
The risk of burns can be further mitigated by electrical safety testing
to minimize the risk of thermal burns to the patient, and specific
instructions regarding proper usage and specific warnings associated
with the risk of burns.
<bullet> The risk of electrical shock can be mitigated by
electrical safety testing to minimize the risk of shock to the patient.
This risk can be further mitigated by labeling that includes
instructions on appropriate usage and maintenance, and specific
warnings regarding electrical shock.
<bullet> The risk of EMI can be mitigated through performance
testing that demonstrates the EMC of the device and labeling to
minimize the risk of adverse interaction with other electronic devices,
such as implanted electronic devices.
<bullet> The risk of adverse tissue reaction can be mitigated by a
biocompatibility evaluation to ensure that the materials used in
patient-contacting components of the device are safe for skin contact
and labeling that includes warnings against use on compromised skin or
when there are known skin sensitivities, as well as validated
instructions on appropriate cleaning of any reusable components.
<bullet> The risk of infection can be mitigated by labeling that
includes validated instructions for appropriate cleaning of any
reusable components.
<bullet> The risk of adverse interaction with internal/external
fixation devices can be mitigated through labeling that includes
appropriate warnings for patients with implanted medical devices, as
well as non-clinical performance testing, which would include an
evaluation of thermal safety and thermal reliability.
<bullet> The risk of adverse biologic effects can be mitigated by
non-clinical performance testing to verify and validate critical
performance characteristics of the device, which include ensuring
thermal safety and reliability, signal characteristics are within safe
physiologic limits, and reliability of the device over the expected
use-life. The risk of adverse biological effects is further mitigated
by software verification, validation, and hazard analysis, which will
help ensure the device operates as intended.
Table 1--Risks to Health and Mitigation Measures for Non-Invasive Bone
Growth Stimulators
------------------------------------------------------------------------
Identified risk to health Mitigation measures
------------------------------------------------------------------------
Failure or delay of osteogenesis....... Clinical performance data.
Non-clinical performance
testing.
Software verification,
validation, and hazard
analysis.
Labeling.
Use error or improper device use....... Labeling comprehension testing.
Labeling.
Burn................................... Non-clinical performance
testing.
Electrical safety testing.
Labeling.
Electrical shock....................... Electrical safety testing.
Labeling.
Electromagnetic interference........... Electromagnetic compatibility
(EMC) testing.
Labeling.
Adverse tissue reaction................ Biocompatibility evaluation.
Labeling.
Infection.............................. Labeling.
Adverse interaction with internal/ Non-clinical performance
external fixation devices. testing.
Labeling.
Adverse biological effects............. Non-clinical performance
testing.
Software verification,
validation, and hazard
analysis.
------------------------------------------------------------------------
V. The Final Order
In this final order, FDA is adopting relevant findings from the
August 17, 2020, proposed order (85 FR 49986). FDA has made revisions
in this final order in response to the Panel deliberations (see section
II) and comments received (see section III). FDA is issuing this final
order to reclassify non-invasive bone growth stimulators from class III
into class II under a new device classification regulation with the
name non-invasive bone growth stimulator, and to establish special
controls by revising 21 CFR part
[[Page 20361]]
890 (adding 21 CFR 890.5870). The identification for Sec. 890.5870(a)
has been revised from the proposed order to provide a more accurate
description of the devices in this classification regulation.
Further, in this final order, FDA has identified the special
controls under section 513(b)(1)(B) of the FD&C Act that, along with
general controls, provide a reasonable assurance of the safety and
effectiveness for non-invasive bone growth stimulators. In this final
order, the Agency has made refinements to the special controls as
previously described in the proposed order to further mitigate the
risks to health associated with the use of non-invasive bone growth
stimulators. Specifically, and among other things, FDA revised certain
special controls for clarity, added imaging criteria to demonstrate
effectiveness, and added a new special control for labeling
comprehension. The clinical data special control now includes a
requirement for imaging to demonstrate fusion at the treatment site as
evidence that the device performs as intended. There is a new special
control for labeling comprehension testing to demonstrate that patients
can correctly use the devices based solely on the instructions for use.
We made other minor revisions to several of the special controls for
clarity.
Under the FD&C Act, 510(k)s are required to reasonably assure the
safety and effectiveness of class II devices unless FDA determines that
the device type should be exempt under section 510(m).\19\ FDA has not
made this determination for non-invasive bone growth stimulators and,
therefore, this class II device type is not exempt from 510(k)
requirements. Thus, under sections 510(k) and 513(f) of the FD&C Act,
persons who intend to market this device type must submit a 510(k)
containing information on non-invasive bone growth stimulators that
they intend to market and must obtain FDA clearance of the device prior
to marketing.
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\19\ In considering whether to exempt class II devices from
premarket notification, FDA considers whether premarket notification
for the type of device is necessary to provide reasonable assurance
of safety and effectiveness of the device. FDA generally considers
the factors initially identified in 63 FR 3142 (January 21, 1998)
and further explained in FDA's guidance ``Procedures for Class II
Device Exemptions from Premarket Notification,'' available at
<a href="http://www.fda.gov/regulatory-information/search-fda-guidance-documents/procedures-class-ii-device-exemptions-premarket-notification-guidance-industry-and-cdrh-staff">www.fda.gov/regulatory-information/search-fda-guidance-documents/procedures-class-ii-device-exemptions-premarket-notification-guidance-industry-and-cdrh-staff</a>, to determine whether premarket
notification is necessary for class II devices. FDA also considers
that even when exempting devices from the 510(k) requirements, these
devices would still be subject to certain limitations on exemptions,
for example, the general limitations set forth in 21 CFR 890.9.
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Under this final order, non-invasive bone growth stimulators are
prescription use devices under Sec. 801.109 (21 CFR 801.109).
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 Sec. 801.109 are met. The device would continue to be
subject to the submission and device clearance requirements of sections
510(k) and 513 of the FD&C Act and of part 807, subpart E of FDA's
regulations (21 CFR part 807).
VI. Effective Date
This final order is effective 30 days after the date of its
publication in the Federal Register.
VII. Analysis of Environmental Impact
The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not normally have a significant effect on the human
environment. Therefore, neither an environmental assessment nor an
environmental impact statement is required.
VIII. Paperwork Reduction Act of 1995
This final order refers to previously approved collections of
information found in FDA regulations. The previously approved
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
807, subpart E (Premarket Notification Procedures), have been approved
under OMB control number 0910-0120; the collections of information in
21 CFR part 820 (Quality Management System Regulation) have been
approved under OMB control number 0910-0073; the collections of
information in 21 CFR part 812 (Investigational Device Exemptions) have
been approved under OMB control number 0910-0078; the collections of
information in 21 CFR part 814, subparts A through E (Premarket
Approval of Medical Devices), have been approved under OMB control
number 0910-0231; and the collections of information under 21 CFR part
801 (Device Labeling) have been approved under OMB control number 0910-
0485.
IX. Codification of Orders
Under section 513(f)(3) of the FD&C Act, FDA may issue final orders
to reclassify devices. FDA will continue to codify classifications and
reclassifications in the Code of Federal Regulations (CFR). Changes
resulting from final orders will appear in the CFR as newly codified
orders. In accordance with section 513(f)(3) of the FD&C Act, we are
codifying in this final order the classification of non-invasive bone
growth stimulators in the new 21 CFR 890.5870, under which these
devices are reclassified from class III into class II.
X. 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 are also 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 final order, please note that websites are subject to change
over time.
* 1. FDA, Sept. 8-9, 2020, Meeting of the Orthopaedic and
Rehabilitation Devices Panel, Meeting Materials: <a href="https://www.fda.gov/advisory-committees/advisory-committee-calendar/september-8-9-2020-orthopaedic-and-rehabilitation-devices-panel-medical-devices-advisory-committee">https://www.fda.gov/advisory-committees/advisory-committee-calendar/september-8-9-2020-orthopaedic-and-rehabilitation-devices-panel-medical-devices-advisory-committee</a>.
2. International Electrotechnical Commission, IEC 60601-1-2 Medical
electrical equipment--Part 1-2: General requirements for basic
safety and essential performance--Collateral Standard:
Electromagnetic disturbances--Requirements and tests, 2014.
(Available at: <a href="https://webstore.iec.ch/en/publication/2590">https://webstore.iec.ch/en/publication/2590</a>.)
* 3. FDA, Sept. 8, 2020, Meeting of the Orthopaedic and
Rehabilitation Devices Panel Transcript: <a href="https://www.fda.gov/media/145159/download">https://www.fda.gov/media/145159/download</a>.
* 4. FDA, P190030 Summary of Safety and Effectiveness Data, December
9, 2020. (Available at: <a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm">https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm</a>?id=P190030.)
* 5. FDA, P210035 Summary of Safety and Effectiveness Data, May 3,
2022. (Available at: <a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm">https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm</a>?id=P210035.)
* 6. FDA, P230025 Summary of Safety and Effectiveness Data, February
9, 2024. (Available at: <a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm">https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm</a>?id=P230025.)
[[Page 20362]]
* 7. FDA, P210016 Summary of Safety and Effectiveness Data, January
17, 2025. (Available at: <a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm">https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm</a>?id=P210016.)
* 8. FDA, ``Requests for Feedback and Meetings for Medical Device
Submissions: The Q-Submission Program; Guidance for Industry and FDA
Staff,'' May 29, 2025. (Available at: <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-medical-device-submissions-q-submission-program">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-medical-device-submissions-q-submission-program</a>.)
* 9. FDA, ``Deciding When to Submit a 510(k) for a Change to an
Existing Device; Guidance for Industry and Food and Drug
Administration Staff,'' October 25, 2017. (Available at: <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-change-existing-device">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-change-existing-device</a>.)
* 10. FDA, ``Deciding When to Submit a 510(k) for a Software Change
to an Existing Device; Guidance for Industry and Food and Drug
Staff,'' October 25, 2017. (Available at: <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-software-change-existing-device">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-software-change-existing-device</a>.)
List of Subjects in 21 CFR Part 890
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321 et seq., as amended) and under authority delegated to the
Commissioner of Food and Drugs, 21 CFR part 890 is amended as follows:
PART 890--PHYSICAL MEDICINE DEVICES
0
1. The authority citation for part 890 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Add Sec. 890.5870 to subpart F to read as follows:
Sec. 890.5870 Non-invasive bone growth stimulator.
(a) Identification. A non-invasive bone growth stimulator is a
prescription device that provides stimulation through electrical,
magnetic, or ultrasonic fields. The device is intended to be used
externally to promote osteogenesis as an adjunct to primary treatments
for fracture fixation and spinal fusion or as a treatment for
established nonunions or failed fusions.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Clinical data must demonstrate that the device performs as
intended under anticipated conditions of use. Imaging data must
demonstrate fusion at the treatment site.
(2) Non-clinical performance testing must demonstrate that the
device performs as intended under anticipated conditions of use.
Critical performance and safety characteristics of the device,
considering the operational modality of the device, must be verified
and validated to ensure:
(i) Intended design outputs are delivered to the patient;
(ii) Thermal safety and thermal reliability;
(iii) Signal characteristics are within safe physiologic limits;
and
(iv) Device reliability is consistent with the expected use-life.
(3) Patient-contacting components of the device must be
demonstrated to be biocompatible.
(4) Performance data must demonstrate the electrical safety and
electromagnetic compatibility of the device.
(5) Appropriate software verification, validation, and hazard
analysis must be performed.
(6) Labeling comprehension testing must demonstrate the patient can
correctly use the device based solely on reading the instructions for
use.
(7) Labeling for the device must include the following:
(i) Warning against use on compromised skin or when there are known
skin sensitivities;
(ii) Appropriate warnings for patients with implanted medical
devices;
(iii) A detailed summary of the supporting clinical data, which
includes the clinical outcomes associated with the use of the device,
and a summary of adverse events and complications that occurred with
the device;
(iv) A clear description of the device;
(v) Instructions on appropriate usage, duration, and frequency of
use;
(vi) Instructions for maintenance and safe disposal;
(vii) Validated instructions for appropriate cleaning of any
reusable components;
(viii) Specific warnings regarding user burns, electrical shock,
and skin irritation; and
(ix) The risks and benefits associated with use of the device when
used as intended.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-07366 Filed 4-15-26; 8:45 am]
BILLING CODE 4164-01-P
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