Medical Devices; Orthopedic Devices; Classification of the Wearable Vibration Device for Orthopedic Use

Issuing agencies

Abstract

The Food and Drug Administration (FDA) is classifying the wearable vibration device for orthopedic use 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 classification of the wearable vibration device for orthopedic use. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Full Text

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<title>Federal Register, Volume 91 Issue 213 (Thursday, November 5, 2026)</title>
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[Federal Register Volume 91, Number 213 (Thursday, November 5, 2026)]
[Rules and Regulations]
[Pages 69692-69694]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-22589]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 888

[Docket No. FDA-2026-N-12211]


Medical Devices; Orthopedic Devices; Classification of the 
Wearable Vibration Device for Orthopedic Use

AGENCY: Food and Drug Administration, HHS.

ACTION: Final amendment; final order.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the 
wearable vibration device for orthopedic use 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 
classification of the wearable vibration device for orthopedic use. We 
are taking this action because we have determined that classifying the 
device into class II will provide a reasonable assurance of the safety 
and effectiveness of the device. We believe this action will also 
enhance patients' access to beneficial innovative devices, in part by 
reducing regulatory burdens.

DATES: This order is effective November 5, 2026. The classification was 
applicable on January 12, 2024.

FOR FURTHER INFORMATION CONTACT: Jesse Muir, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4462, Silver Spring, MD 20993-0002, 240-402-6679, 
<a href="/cdn-cgi/l/email-protection#561c33252533781b233f2416303237783e3e2578313920"><span class="__cf_email__" data-cfemail="6228071111074c2f170b10220406034c0a0a114c050d14">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA (the Agency or we) has classified the wearable 
vibration device for orthopedic use into class II (special controls), 
which we have determined will provide a reasonable assurance of the 
safety and effectiveness of the device. In addition, we believe this 
action will enhance patients' access to beneficial innovation, in part 
by reducing regulatory burdens 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 into, and remains 
within, class III and requires premarket approval unless and until FDA 
takes an action to classify or

[[Page 69693]]

reclassify the device (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 (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 (see also part 860, subpart D (21 CFR part 860, subpart D)). 
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 
classification 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 premarket 
notification (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.
    We believe this De Novo classification will enhance patients' 
access to beneficial innovation, in part by reducing regulatory 
burdens. 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 17, 2023, FDA received Bone Health Technologies, Inc.'s 
request for De Novo classification of the Osteoboost Belt. 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 the safety and 
effectiveness of the device, 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 section 513(a)(1)(B) of the 
FD&C Act). 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 January 12, 2024, 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 
888.5895.\1\ We have named the generic type of device ``wearable 
vibration device for orthopedic use,'' and it is identified as a 
wearable device that uses mechanical vibrations, targeted to specific 
regions of the skeleton, to reduce loss of bone strength or bone 
mineral density.
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    \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.
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    FDA has identified the risks to health associated with this type of 
device and the measures required to mitigate these risks in table 1.

 Table 1--Risks to Health and Mitigation Measures for Wearable Vibration
                       Devices for Orthopedic Use
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       Identified risks to health              Mitigation measures
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Accelerated loss of bone strength and    Clinical performance testing;
 bone mineral density resulting from      Non-clinical performance
 application of inappropriate magnitude   testing; Software
 and/or frequency of vibration.           verification, validation, and
                                          hazard analysis;
                                          Electromagnetic compatibility
                                          testing; and Labeling.
Adverse tissue reaction................  Biocompatibility evaluation.
Patient injury due to electrical,        Electrical safety testing;
 mechanical, or thermal hazards.          Electromagnetic compatibility
                                          testing; Mechanical and
                                          thermal safety testing;
                                          Software verification,
                                          validation, and hazard
                                          analysis; and Labeling.
Adverse effects on the patient,          Clinical performance testing;
 including regional pain, dizziness,      and Labeling.
 blurred vision, muscle weakness,
 difficulty with balance, headache, and
 nausea.
User error leading to ineffective        Clinical performance testing;
 reduction in loss of bone strength or    Human factors/usability
 bone mineral density.                    evaluation; and Labeling.
------------------------------------------------------------------------


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    FDA has determined that special controls, in combination with the 
general controls, address these risks to health and provide reasonable 
assurance of the safety and effectiveness of the device. 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 final order.
    Under the FD&C Act, submission of a premarket notification under 
section 510(k) is 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) of the FD&C Act. At this 
time FDA has not made this determination for wearable vibration devices 
for orthopedic use. This device is therefore subject to premarket 
notification requirements under section 510(k) of the FD&C Act.

III. Analysis of Environmental Impact

    We have 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.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to 
previously 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 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 management system regulation have been approved under 
OMB control number 0910-0073; and the collections of information in 21 
CFR part 801 regarding labeling have been approved under OMB control 
number 0910-0485.

List of Subjects in 21 CFR Part 888

    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 
888 is amended as follows:

PART 888--ORTHOPEDIC DEVICES

0
1. The authority citation for part 888 continues to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.


0
2. Add Sec.  888.5895 to subpart E to read as follows:


Sec.  888.5895  Wearable vibration device for orthopedic use.

    (a) Identification. A wearable vibration device for orthopedic use 
is a wearable device that uses mechanical vibrations, targeted to 
specific regions of the skeleton, to reduce loss of bone strength or 
bone mineral density.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical performance testing must demonstrate that the device 
performs as intended under anticipated conditions of use. Testing must 
evaluate the reduction in loss of bone strength or bone mineral 
density. Testing must evaluate patient risks, including regional pain, 
dizziness, blurred vision, muscle weakness, difficulty with balance, 
headache, and nausea. The testing must include a minimum of 1 year of 
follow-up.
    (2) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use. The 
following must be provided:
    (i) Characterization of the designed outputs of the device;
    (ii) Demonstration of the reliability and reproducibility of device 
output; and
    (iii) Validation that vibration characteristics received by the 
patient are within safe physiologic limits.
    (3) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (4) Performance data must be provided to demonstrate the electrical 
safety, mechanical safety, thermal safety, battery safety, and 
electromagnetic compatibility of the device.
    (5) Software verification, validation, and hazard analysis must be 
performed.
    (6) Human factors or usability evaluation must demonstrate that the 
user can correctly use the device, based solely on reading the 
directions for use.
    (7) Labeling must include the following:
    (i) A summary of the clinical performance testing with the device, 
including clinical outcomes and observed adverse events;
    (ii) Information regarding limitations of the clinical significance 
of the clinical performance testing;
    (iii) Instructions on duration and frequency of use, and when to 
discontinue use of the device; and
    (iv) Instructions for device maintenance, including appropriate 
cleaning of any reusable components and safe disposal of the device.

Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-22589 Filed 11-4-26; 8:45 am]
BILLING CODE 4164-01-P


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