Notice2026-11303
Intent To Exempt Certain Unclassified Medical Devices From Premarket Notification Requirements; Guidance for Industry and Food and Drug Administration Staff; Availability
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Published
June 5, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is announcing the availability of the guidance "Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements." This guidance describes FDA's intent to exempt certain unclassified medical devices from premarket notification requirements. At this time, and based on the information currently available to the Agency, FDA believes the devices identified in this guidance meet the standards for exemption from premarket notification. This guidance has been implemented without prior comment, but it remains subject to comment in accordance with the Agency's good guidance practices.
Full Text
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<title>Federal Register, Volume 91 Issue 108 (Friday, June 5, 2026)</title>
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[Federal Register Volume 91, Number 108 (Friday, June 5, 2026)]
[Notices]
[Pages 34240-34242]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-11303]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-0967]
Intent To Exempt Certain Unclassified Medical Devices From
Premarket Notification Requirements; Guidance for Industry and Food and
Drug Administration Staff; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance ``Intent to Exempt Certain Unclassified
Medical Devices from Premarket Notification Requirements.'' This
guidance describes FDA's intent to exempt certain unclassified medical
devices from premarket notification requirements. At this time, and
based on the information currently available to the Agency, FDA
believes the devices identified in this guidance meet the standards for
exemption from premarket notification. This guidance has been
implemented without prior comment, but it remains subject to comment in
accordance with the Agency's good guidance practices.
DATES: The announcement of the guidance is published in the Federal
Register on June 5, 2026.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2014-D-0967 for ``Intent to Exempt Certain Unclassified Medical
Devices from Premarket Notification Requirements.'' Received comments
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
[[Page 34241]]
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document titled
``Intent to Exempt Certain Unclassified Medical Devices from Premarket
Notification Requirements'' to the Office of Policy, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5441, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your request.
FOR FURTHER INFORMATION CONTACT: Erica Takai, Center for Devices and
Radiological Health, Food and Drug Administration, 301-796-6353.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance titled ``Intent to
Exempt Certain Unclassified Medical Devices from Premarket Notification
Requirements.''
In the commitment letter (section I.G of the Performance Goals and
Procedures) that was drafted as part of the reauthorization process for
the Medical Device User Fee Amendments of 2012, part of the Food and
Drug Administration Safety and Innovation Act (Pub. L. 112-144), FDA
committed to proposing low-risk medical devices to exempt from
premarket notification (510(k)) requirements. This guidance describes
FDA's intent to exempt certain unclassified medical devices (that FDA
intends to propose classifying into class I or II) from premarket
notification requirements. At this time, FDA believes the devices being
added to this guidance meet the standards for exemption from premarket
notification requirements. Until such exemption occurs, or until FDA
becomes aware of new information affecting its current understanding,
FDA does not intend to enforce compliance with 510(k) requirements for
these devices. Due to this enforcement policy, FDA does not expect
manufacturers to submit 510(k)s for these devices during this time
period.
This updated guidance supersedes the June 2019 guidance of the same
title, ``Intent to Exempt Certain Unclassified Medical Devices from
Premarket Notification Requirements.'' The updated guidance includes
five additional product codes that have been independently considered
by panels and were recommended as appropriate for classification into
class I or class II. FDA's current assessment is that these device
types meet the standards for exemption from premarket notification. The
five product codes included in the update to the guidance are: LDK-
Device, sensing, optical contour; MVV-Device, acupressure; MQZ-
Prosthesis, nail; MIG-Strip, test isoniazid; and LXQ-Cup, eye.
This guidance is being implemented without prior public comment
because the Agency has determined that prior public participation is
not feasible or appropriate (see section 701(h)(1)(C) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 371(h)(1)(C)) and 21 CFR
10.115(g)(2)). FDA has determined that this guidance presents a less
burdensome policy that is consistent with public health. Although this
guidance is being implemented immediately without prior comment, it
remains subject to comment in accordance with the Agency's good
guidance practices(21 CFR 10.115(g)(3)(i)(D)). FDA will consider all
comments received and revise the guidance as appropriate.
The guidance represents the current thinking of FDA on the intent
to exempt certain unclassified medical devices from premarket
notification requirements. It does not establish any rights for any
person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.
II. Electronic Access
Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at <a href="https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products">https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products</a>. This guidance document is also
available at <a href="https://www.regulations.gov">https://www.regulations.gov</a>, and <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics</a>. Persons unable to download an electronic copy of
``Intent to Exempt Certain Unclassified Medical Devices from Premarket
Notification Requirements'' may send an email request to <a href="/cdn-cgi/l/email-protection#4b080f1903660c3e222f2a25282e0b2d2f2a65232338652c243d"><span class="__cf_email__" data-cfemail="89cacddbc1a4cefce0ede8e7eaecc9efede8a7e1e1faa7eee6ff">[email protected]</span></a> to receive an electronic copy of the document.
Please use the document number GUI01300046 and complete title to
identify the guidance you are requesting.
III. Paperwork Reduction Act of 1995
While this guidance contains no new collection of information, it
does refer to previously approved FDA collections of information. 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 (PRA) (44 U.S.C. 3501-3521). The collections of information
in the following table have been approved by OMB:
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21 CFR part; guidance; or FDA
form Topic OMB control No.
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807, subpart E.................. Premarket 0910-*0120
notification.
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[[Page 34242]]
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-11303 Filed 6-4-26; 8:45 am]
BILLING CODE 4164-01-P
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