Notice2026-05329
Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notifications Submission
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Published
March 19, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the applicable regulations, and the guidance documents and agency forms related to Premarket Notifications of Devices.
Full Text
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<title>Federal Register, Volume 91 Issue 53 (Thursday, March 19, 2026)</title>
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[Federal Register Volume 91, Number 53 (Thursday, March 19, 2026)]
[Notices]
[Pages 13310-13313]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-05329]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-1849]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Premarket Notifications Submission
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the applicable regulations, and the
guidance documents and agency forms related to Premarket Notifications
of Devices.
DATES: Either electronic or written comments on the collection of
information must be submitted by May 18, 2026.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing
[[Page 13311]]
system will accept comments until 11:59 p.m. Eastern Time at the end of
May 18, 2026. Comments received by mail/hand delivery/courier (for
written/paper submissions) will be considered timely if they are
received on or before that date.
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-2026-N-1849 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Premarket Notifications
Submission.'' Received comments, those filed in a timely manner (see
ADDRESSES), 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>.
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.
FOR FURTHER INFORMATION CONTACT: Amber Barrett, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
<a href="/cdn-cgi/l/email-protection#e8b8baa9bb9c898e8ea88e8c89c680809bc68f879e"><span class="__cf_email__" data-cfemail="e9b9bba8ba9d888f8fa98f8d88c781819ac78e869f">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Premarket Notifications Submission 510(k)--21 CFR, Part 807, Subpart E
OMB Control Number 0910-0120--Extension
This information collection helps support implementation of
statutory provisions that govern premarket clearance of devices.
Section 510(k) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 360(k)) and implementing regulations in part 807, subpart E
(21 CFR part 807, subpart E), establish premarket notification
procedures. Persons who intend to market a medical device, for which a
premarket approval application (PMA) is not required, must submit a
premarket notification to FDA, unless the device is exempt from 510(k)
requirements and does not exceed the limitations of exemptions of the
device classification regulations, at least 90 days before proposing to
begin the introduction, or delivery for introduction into interstate
commerce, for commercial distribution of a device intended for human
use. Based on the information provided in the notification, FDA must
determine whether the new device is substantially equivalent to a
legally marketed device. If a device is determined to be not
substantially equivalent to a legally marketed device, it must have an
approved PMA, product development
[[Page 13312]]
protocol, humanitarian device exemption (HDE), request for an
evaluation of automatic class III designation (De Novo request), or be
reclassified into class I or class II before being marketed. The
information collection also helps support section 510(l) of the FD&C
Act, which provides for exemption from premarket notification.
The following instruments are included in the information
collection:
<bullet> Form FDA 3514, ``CDRH Premarket Review Submission Cover
Sheet''
<bullet> Form FDA 3881, ``Indications for Use''
<bullet> Voluntary eSTAR Program Interactive PDF Form and instructional
web page
<bullet> Form FDA 4062, ``Electronic Submission Template and Resource
(eSTAR)'' (for non-In Vitro Diagnostic (IVD) 510(k) submissions)
<bullet> Form FDA 4078, ``Electronic Submission Template and Resource
(eSTAR)'' (for In Vitro Diagnostic (IVD) 510(k) submissions)
We are revising the information collection to include Form FDA
3674, ``Certification of Compliance, Under 42 U.S.C. 282(j)(5)(B), with
Requirements of <a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a>.'' Under applicable authorities,
applications under sections 505, 515, or 520(m) of the FD&C Act (21
U.S.C. 355, 360e, or 360j(m)), or under section 351 of the Public
Health Service Act (42 U.S.C. 262), or submission of a report under
section 510(k) of the FD&C Act, must be accompanied by a certification.
Where available, such certification must include the appropriate
National Clinical Trial numbers.
The information collection also includes an ``Acceptance
Checklist.'' As discussed in the guidance document ``Refuse to Accept
Policy for 510(k)s'' (April 2022), available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/refuse-accept-policy-510ks">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/refuse-accept-policy-510ks</a>, we believe the checklist can be a helpful resource for
510(k) submitters and may simplify preparation of the 510(k).
Similarly, the guidance document ``Recognition and Withdrawal of
Voluntary Consensus Standards'' (September 2020), available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recognition-and-withdrawal-voluntary-consensus-standards">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recognition-and-withdrawal-voluntary-consensus-standards</a>, communicates
procedures followed by the Center for Devices and Radiological Health
(CDRH) when requests for recognition of a voluntary consensus standard
for medical products are received. The guidance document outlines
principles for recognizing a standard wholly, partly, or not at all, as
well as reasons and rationales for withdrawing a standard. Section 514
of the FD&C Act (21 U.S.C. 360d) allows FDA to recognize consensus
standards developed by international and national organizations for use
in satisfying portions of device premarket review submissions,
including premarket notifications or other requirements. We publish and
update the list of recognized standards regularly at <a href="https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm">https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm</a>. As instructed in the guidance document, any interested
party may submit a request for recognition of a standard by mail
directed to the CDRH Standards Program (i.e., paper copy) or
electronically via email.
For efficiency of Agency operations, we are also revising the
information to include activities associated with section 520(b) of the
FD&C Act, governing custom devices. Regulations in 21 CFR 812.3 define
a custom device and implementing regulations in 21 CFR 807.85 provide
for exemption from premarket notification. Section 520(b) of the FD&C
Act also provides for the issuance of guidance. The guidance document
entitled, ``Custom Device Exemption'' (September 2014), and available
for download at <a href="https://www.fda.gov/media/89897/download">https://www.fda.gov/media/89897/download</a>, explains how
FDA interprets provisions in section 520(b)(2)(B) of the FD&C Act,
describes what information should be submitted in a Custom Device
Annual Report (``annual report''), and provides recommendations on how
to submit an annual report for devices distributed under the custom
device exemption.
Finally, we discuss the guidance document entitled, ``Transition
Plan for Medical Devices That Fall Within Enforcement Policies Issued
During the Coronavirus Disease 2019 (COVID-19) Public Health
Emergency,'' announced in the Federal Register of March 27, 2023 (88 FR
18153), which describes a phased approach intended to help avoid
disruption in device supply and help facilitate compliance with
applicable legal requirements. The recommendations discussed in the
guidance document result in the one-time collection of information
intended to ensure an orderly and transparent transition from temporary
policies established during the COVID-19 public health emergency to
normal operations. Because the information collection recommendations
apply to specific medical devices already in distribution, we believe
the information discussed is appropriately characterized as
nonstandardized followup designed to clarify responses to approved
collections of information (i.e., plans for compliance with applicable
requirements unique to that distributed device). We therefore believe
the activity constitutes the collection of non-identical and/or
followup information, as defined under 5 CFR 1320.3. At the same time,
we expect some degree of fluctuation in future submissions under part
807, subpart E, as a result of implementation of the medical device
transition plan.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden
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Number of Total
Activity and 21 CFR part/section Form No. Number of responses per annual Average burden per response Total
respondents respondent responses hours
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21 CFR Part 807, Subpart E, PREMARKET NOTIFICATION PROCEDURES
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510(k) submission (807 subpart E)...... FDA 3881.................. 3,800 1 3,800 79.25.......................... 301,150
Summary cover sheet (807.87)........... FDA 3514.................. 1,906 1 1,906 0.5............................ 953
Status request (807.90(a)(3)).......... .......................... 1 1 1 0.25........................... 1
510(k) summary (807.92)................ .......................... 2,742 1 2,742 4.............................. 10,968
510(k) statement (807.93).............. .......................... 130 1 130 .08 (5 minutes)................ 10
510(k) submission (807 subpart E)-- FDA 4062, FDA 4078........ 3,800 1 3,800 40............................. 152,000
using eSTAR format.
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Guidance Document Recommendations
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Request for recognition of a voluntary .......................... 5 1 5 1.............................. 5
consensus standard.
Annual reporting for custom devices .......................... 31 1 31 40............................. 1,240
under 520(b) of the FD&C Act.
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[[Page 13313]]
42 CFR part 11, Clinical Trials Registration and Results Information Submission, subparts D and E; and FDA Guidance ``Form FDA 3674--Certifications To
Accompany Drug, Biological Product, and Device Applications/Submissions''
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Certification to accompany 510(k) FDA 3674.................. 3,800 1 3,800 0.75 (45 minutes).............. 2,850
submissions.
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Electronic Submission Template and Resource (eSTAR)
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eSTAR setup--one-time burden........... .......................... 80 1 80 0.08 (5 minutes)............... 6
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Total.............................. .......................... ............ .............. 16,295 ............................... 469,183
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The information collection reflects program changes and
adjustments. We have also made nominal adjustments on individual
provisions to reflect expected fluctuations in submissions.
Cumulatively these actions result in an overall increase of 145,804
hours and a corresponding increase of 3,625 responses annually. The
increase was attributed to the 510(k) submissions increase from 100 to
3,800.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-05329 Filed 3-18-26; 8:45 am]
BILLING CODE 4164-01-P
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