SUPPLEMENTARY INFORMATION:

I. Background

Section 745A(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 379k-1(b)), amended by section 207 of the FDA Reauthorization Act of 2017 (Pub. L. 115-52), requires that presubmissions and submissions for devices under section 510(k), 513(f)(2)(A), 515(c), 515(d), 515(f), 520(g), 520(m), or 564 of the FD&C Act (21 U.S.C. 360(k), 360c(f)(2)(A), 360e(c), 360e(d), 360e(f), 360j(g), 360j(m), or 360bbb-3) or section 351 of the Public Health Service Act (42 U.S.C. 262) and any supplements to such presubmissions or submissions, including appeals of those submissions, be submitted in electronic format specified by FDA beginning on such date as specified by FDA in final guidance. It also mandates that FDA issue a draft guidance not later than October 1, 2019, providing for further standards for the submission by electronic format, a timetable for establishment of these further standards, and criteria for waivers of and exemptions from the requirements.

In addition, in the Medical Device User Fee Amendments of 2017 (MDUFA IV) Commitment Letter ^[1] from the Secretary of Health and Human Services to Congress, FDA committed to developing “electronic submission templates that will serve as guided submission preparation tools for industry to improve submission consistency and enhance efficiency in the review process” and “[b]y FY [fiscal year] 2020, the Agency will issue a draft guidance document on the use of the electronic submission templates.” In addition, the Commitment Letter states that “[n]o later than 12 months after the close of the public comment period, the Agency will issue a final guidance.” FDA's guidance document “Providing Regulatory Submissions for Medical Devices in Electronic Format—Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act” issued July 15, 2020, (the “parent guidance”) ^[2] was intended to satisfy the final guidance documents referenced in section 745A(b)(3) of the FD&C Act and the MDUFA IV Commitment Letter. A notice of availability of the parent guidance appeared in the Federal Register of July 15, 2020 (85 FR 42864).

In the parent guidance, the Agency concluded that it is not feasible to describe and implement the electronic format(s) that would apply to all the submissions covered by section 745A(b) of the FD&C Act in one guidance document. Accordingly, the parent guidance describes how FDA interprets and plans to implement the requirements of section 745A(b)(3) of the FD&C Act, while individual guidances will be developed to specify the formats for specific submissions and corresponding timetables for implementation.

This final guidance “Electronic Submission Template for Medical Device 510(k) Submissions” is the first of these individual guidances that provides further standards for the submission of 510(k)s by electronic format, a timetable for establishment of these further standards, and criteria for waivers of and exemptions from the requirements. At this time, the electronic Submission Template And ( printed page 57912) Resource (eSTAR) is the only electronic submission template available to prepare a complete 510(k) electronic submission using the guided prompts for the collection of structured and unstructured data.

All 510(k) submissions, including original submissions for Traditional, Special, and Abbreviated 510(k)s, and subsequent Supplements and Amendments (amendments include add-to-files and appeals), and any other subsequent submissions to an original submission unless exempted in this final guidance, will be required to be submitted as electronic submissions as specified in the guidance. Section 745A(b)(2) of the FD&C Act allows for FDA to set forth criteria for exemptions and waivers from electronic submission requirements. FDA has identified such criteria in the final guidance document. FDA is identifying October 1, 2023, as the date on which the 510(k) electronic submission requirements will take effect.

A notice of availability of the draft guidance appeared in the Federal Register of September 29, 2021 (86 FR 53965). FDA considered comments received and revised the guidance as appropriate in response to the comments, including updated criteria for exemptions; clarification of the technical screening hold; and description of the transition period and effective date on which 510(k) electronic submissions will be required.

In section 745A(b) of the FD&C Act, Congress granted explicit statutory authorization to FDA to specify in guidance the statutory requirement for electronic submissions solely in electronic format by providing standards, a timetable, and criteria for waivers and exemptions. To the extent that this final guidance provides such requirements under section 745A(b)(3) of the FD&C Act ( i.e., standards, timetable, criteria for waivers of and exemptions), indicated by the use of the mandatory words, such as must or required, this document is not subject to the usual restrictions in FDA's good guidance practice regulations, such as the requirement that guidances not establish legally enforceable responsibilities. (See § 10.115(d).)

To the extent that this final guidance describes recommendations that are not standards, timetable, criteria for waivers of, or exemptions under section 745A(b)(3) of the FD&C Act, it is being issued in accordance with FDA's good guidance practices regulation (§ 10.115). This guidance represents the current thinking of FDA on this topic. 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. This final guidance contains both binding and nonbinding provisions.

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 https://www.fda.gov/​medical-devices/​device-advice-comprehensive-regulatory-assistance/​guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also available at https://www.regulations.gov, https://www.fda.gov/​regulatory-information/​search-fda-guidance-documents, or https://www.fda.gov/​vaccines-blood-biologics/​guidance-compliance-regulatory-information-biologics. Persons unable to download an electronic copy of “Electronic Submission Template for Medical Device 510(k) Submissions” may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 19006 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. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in the following FDA regulations and forms have been approved by OMB as listed in the following table: