Notice2026-07613
Compliance Policy Regarding Premarket and Other Requirements for Certain NIOSH Approved Air-Purifying Respirators; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Primary source
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Published
April 20, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Compliance Policy Regarding Premarket and Other Requirements for Certain NIOSH Approved Air-Purifying Respirators." This draft guidance document provides a proposed compliance policy for and information about respirators approved by the Centers for Disease Control and Prevention (CDC) National Institute for Occupational Safety and Health (NIOSH) in accordance with 42 CFR part 84, specifically: surgical N95 respirators and N95 filtering facepiece respirators (FFRs) classified under 21 CFR 878.4040; other NIOSH approved, non-surgical respirators including powered air-purifying respirators (PAPRs), non-powered, air-purifying particulate FFRs, and reusable respirators (e.g., elastomeric half and full facepiece respirators); and FFRs for use by the general public in public health medical emergencies classified under 21 CFR 880.6260. These devices are collectively referred to in the guidance and this notice as "certain FFRs and reusable respirators." This guidance, once finalized, is intended to facilitate more efficient and effective use of resources, consistent with the least burdensome policies for devices. This draft guidance is not final nor is it for implementation at this time.
Full Text
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<title>Federal Register, Volume 91 Issue 75 (Monday, April 20, 2026)</title>
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[Federal Register Volume 91, Number 75 (Monday, April 20, 2026)]
[Notices]
[Pages 21003-21005]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-07613]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-D-7121]
Compliance Policy Regarding Premarket and Other Requirements for
Certain NIOSH Approved Air-Purifying Respirators; Draft Guidance for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 or Agency) is announcing
the availability of the draft guidance entitled ``Compliance Policy
Regarding Premarket and Other Requirements for Certain NIOSH Approved
Air-Purifying Respirators.'' This draft guidance document provides a
proposed compliance policy for and information about respirators
approved by the Centers for Disease Control and Prevention (CDC)
National Institute for Occupational Safety and Health (NIOSH) in
accordance with 42 CFR part 84, specifically: surgical N95 respirators
and N95 filtering facepiece respirators (FFRs) classified under 21 CFR
878.4040; other NIOSH approved, non-surgical respirators including
powered air-purifying respirators (PAPRs), non-powered, air-purifying
particulate FFRs, and reusable respirators (e.g., elastomeric half and
full facepiece respirators); and FFRs for use by the general public in
public health medical emergencies classified under 21 CFR 880.6260.
These devices are collectively referred to in the guidance and this
notice as ``certain FFRs and reusable respirators.'' This guidance,
once finalized, is intended to facilitate more efficient and effective
use of resources, consistent with the least burdensome policies for
devices. This draft guidance is not final nor is it for implementation
at this time.
DATES: Submit either electronic or written comments on the draft
guidance by June 22, 2026 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance 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-2025-D-7121 for ``Compliance Policy Regarding Premarket and Other
Requirements for Certain NIOSH Approved Air-Purifying Respirators.''
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 between 9 a.m. and 4 p.m., Monday through
Friday, at the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 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>.
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 entitled
``Enforcement Policy for Premarket and Other Requirements for Certain
NIOSH Approved Respirators'' to the Office of Policy, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive
[[Page 21004]]
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 has a long history of coordinating with NIOSH to help ensure
that respirators used for medical purposes are safe, effective, and
available. All the devices that are within scope of this guidance
document are also subject to approval by NIOSH in accordance with 42
CFR part 84.
Since 1988, surgical N95 respirators that are intended to be worn
by operating room personnel during surgical procedures to protect both
the surgical patient and the operating room personnel from transfer of
microorganisms, body fluids, and particulate material generally have
been classified as class II devices under 21 CFR 878.4040. Likewise,
N95 FFRs used in healthcare settings during other procedures, including
dental, isolation, and other medical procedures, to protect both the
patient and healthcare personnel, are also generally classified as
class II devices under 21 CFR 878.4040. In November 2017, FDA entered
into a Memorandum of Understanding (MOU) with NIOSH, which outlines an
agreement between the agencies conditioned on certain surgical N95
respirators and N95 FFRs becoming exempt from premarket notification
requirements under section 510(k) of the FD&C Act. The MOU became
effective on May 17, 2018, when FDA issued a final order exempting from
510(k) requirements certain surgical N95 respirators and N95 FFRs
(product code MSH), subject to certain conditions and limitations.
FDA considers other types of non-surgical respirators, including:
PAPRs, non-powered air-purifying particulate FFRs (e.g., N95, N99
FFRs), and reusable respirators (e.g., elastomeric half and full
facepiece respirators), that are NIOSH Approved and intended to prevent
wearer exposure to pathogenic biological airborne particulates and used
in healthcare settings, to be postamendments devices. A postamendments
device for which FDA has not issued a classification order (or
reclassification order under section 513(f)(3) of the FD&C Act) is
referred to as a ``not-classified device,'' and is one for which the
Agency has not yet reviewed a marketing application or for which the
Agency has not made a final decision on such a marketing application.
In 2020, FDA addressed its policy regarding not-classified, NIOSH
Approved FFRs and reusable respirators when it took a number of actions
to help address the COVID-19 public health emergency, including issuing
emergency use authorizations (EUAs) for such devices with a medical
purpose. On March 2, 2020, FDA issued an EUA authorizing NIOSH Approved
FFRs to be distributed to healthcare personnel for use in healthcare
settings intended to prevent wearer exposure to pathogenic biological
airborne particulates. On March 11, 2020, FDA clarified that such
respirators are devices because they are intended for a medical use,
i.e., to mitigate further transmission of COVID-19.
In 2007, FDA issued a final rule that classified FFRs for use by
the general public in public health emergencies under 21 CFR 880.6260
as class II devices. In issuing the classification regulation for this
type of device, FDA also issued a special control requiring that, among
other things, this device type be certified by NIOSH as a non-powered
air-purifying particulate respirator with a minimum filtration
efficiency classification of N95.
FDA is proposing the compliance policy described in the draft
guidance for certain FFRs and reusable respirators based on NIOSH's
regulatory oversight of these devices, including the performance
characteristics of these devices, and FDA's review of its postmarket
data. These devices may provide a public health benefit in accordance
with current CDC respiratory virus prevention recommendations. This
guidance, once finalized, is intended to facilitate more efficient and
effective use of resources, consistent with the least burdensome
policies for devices.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). This draft guidance,
once finalized, will represent the current thinking of FDA on
``Compliance Policy Regarding Premarket and Other Requirements for
Certain NIOSH Approved Air-Purifying Respirators.'' 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. As we develop
final guidance on this topic, FDA will consider comments on costs or
cost savings the guidance may generate, relevant for Executive Order
14192.
II. Electronic Access
Persons interested in obtaining a copy of the draft 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>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>. Persons unable to
download an electronic copy of ``Compliance Policy Regarding Premarket
and Other Requirements for Certain NIOSH Approved Air-Purifying
Respirators'' may send an email request to <a href="/cdn-cgi/l/email-protection#185b5c4a50355f6d717c79767b7d587e7c793670706b367f776e"><span class="__cf_email__" data-cfemail="064542544e2b41736f626768656346606267286e6e7528616970">[email protected]</span></a> to
receive an electronic copy of the document. Please use the document
number GUI00007063 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 OMB control
form Topic No.
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807, subpart E................. Premarket notification. 0910-0120
800, 801, and 830.............. Medical Device Labeling 0910-0485
Regulations; Unique
Device Identification.
803............................ Medical Device 0910-0437
Reporting.
806............................ Medical Devices; 0910-0359
Reports of Corrections
and Removals.
807, subparts A through D...... Medical Device 0910-0625
Registration and
Listing.
814, subparts A through E...... Premarket approval..... 0910-0231
[[Page 21005]]
860, subpart D................. De Novo classification 0910-0844
process.
``Requests for Feedback and Q-submissions and Early 0910-0756
Meetings for Medical Device Payor Feedback Request
Submissions: The Q-Submission Programs for Medical
Program''. Devices.
820............................ Current Good 0910-0073
Manufacturing Practice
(CGMP); Quality
Management Systems
(QMSR) Regulation.
``Emergency Use Authorization Emergency Use 0910-0595
of Medical Products and Authorization.
Related Authorities'' and
section 564 of the FD&C Act.
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Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-07613 Filed 4-17-26; 8:45 am]
BILLING CODE 4164-01-P
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