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Notice

Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notifications Submission

A Notice by the Food and Drug Administration on 03/19/2026

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3. Document Details Published Content - Document Details Agencies Department of Health and Human Services Food and Drug Administration Agency/Docket Number Docket No. FDA-2026-N-1849 Document Citation 91 FR 13310 Document Number 2026-05329 Document Type Notice Pages 13310-13313 (4 pages) Publication Date 03/19/2026 Published Content - Document Details

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• Document Details Published Content - Document Details Agencies Department of Health and Human Services Food and Drug Administration Agency/Docket Number Docket No. FDA-2026-N-1849 Document Citation 91 FR 13310 Document Number 2026-05329 Document Type Notice Pages 13310-13313 (4 pages) Publication Date 03/19/2026 Published Content - Document Details
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  • AGENCY:
  • ACTION:
  • SUMMARY:
  • DATES:
  • ADDRESSES:
  • FOR FURTHER INFORMATION CONTACT:
  • SUPPLEMENTARY INFORMATION:
  • Premarket Notifications Submission 510(k)— 21 CFR, Part 807, Subpart E
  • OMB Control Number 0910-0120—Extension Enhanced Content - Table of Contents

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Department of Health and Human Services

Food and Drug Administration

1. [Docket No. FDA-2026-N-1849]

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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 https://www.regulations.gov electronic filing ( printed 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:

• Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov 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 https://www.regulations.gov.
• 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:

• 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.

• 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 https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.

• 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 https://www.regulations.gov. 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: https://www.govinfo.gov/​content/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf.
  Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov 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, PRAStaff@fda.hhs.gov.

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 ( printed 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:

• Form FDA 3514, “CDRH Premarket Review Submission Cover Sheet”
• Form FDA 3881, “Indications for Use”
• Voluntary eSTAR Program Interactive PDF Form and instructional web page
• Form FDA 4062, “Electronic Submission Template and Resource (eSTAR)” (for non-In Vitro Diagnostic (IVD) 510(k) submissions)
• 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 ClinicalTrials.gov. ” 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 https://www.fda.gov/​regulatory-information/​search-fda-guidance-documents/​refuse-accept-policy-510ks, 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 https://www.fda.gov/​regulatory-information/​search-fda-guidance-documents/​recognition-and-withdrawal-voluntary-consensus-standards, 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 https://www.fda.gov/​MedicalDevices/​DeviceRegulationandGuidance/​Standards/​ucm123792.htm. 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 https://www.fda.gov/​media/​89897/​download, 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:

| Activity and 21 CFR part/section | Form No. | Number of
respondents | Number of
responses per

respondent | Total
annual

responses | Average burden
per response | Total
hours |
| --- | --- | --- | --- | --- | --- | --- |
| 21 CFR Part 807, Subpart E, PREMARKET NOTIFICATION PROCEDURES | | | | | | |
| 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)—using eSTAR format | FDA 4062, FDA 4078 | 3,800 | 1 | 3,800 | 40 | 152,000 |
| Guidance Document Recommendations | | | | | | |
| Request for recognition of a voluntary consensus standard | | 5 | 1 | 5 | 1 | 5 |
| Annual reporting for custom devices under 520(b) of the FD&C Act | | 31 | 1 | 31 | 40 | 1,240 |
| ( printed 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” | | | | | | |
| Certification to accompany 510(k) submissions | FDA 3674 | 3,800 | 1 | 3,800 | 0.75 (45 minutes) | 2,850 |
| Electronic Submission Template and Resource (eSTAR) | | | | | | |
| eSTAR setup—one-time burden | | 80 | 1 | 80 | 0.08 (5 minutes) | 6 |
| Total | | | | 16,295 | | 469,183 |
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

Published Document: 2026-05329 (91 FR 13310)