Providing Regulatory Submissions for Medical Devices in Electronic Format — Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act (Draft Guidance — September 2019)

Providing Regulatory Submissions for Medical Devices in Electronic Format — Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act (Draft Guidance — September 2019)

[Note: A final version of this guidance was issued in July 2020.]

Section 745A(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), amended by section 207 of the FDA Reauthorization Act of 2017 (FDARA) (Pub. L. 115-521), requires that pre-submissions 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 this Act or section 351 of the Public Health Service Act, and any supplements to such pre-submissions or submissions, including appeals of those submissions, be submitted in electronic format specified by the Food and Drug Administration (FDA or the Agency) beginning on such date as specified by FDA in final guidance. It also mandates that FDA issue draft guidance not later than October 1, 2019, providing for further standards for the submission by electronic format, a timetable for establishment of these further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 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consistency and enhance efficiency in the review process” and “[by] FY [fiscal year] 2020, the Agency will issue a draft guidance document on the use of the electronic submission templates.” This guidance is intended to satisfy the draft guidance documents referenced in section 745A(b)(3) and the MDUFA IV Commitment Letter.

The Agency has 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)(3) in one guidance document. Accordingly, this guidance describes how FDA interprets and plans to implement the requirements of section 745A(b)(3), while individual guidances will be developed to specify the formats for specific submissions and corresponding timetables for implementation. Specifically, this guidance discusses (1) the submission types that must be submitted electronically, (2) the timetable and process for implementing the requirements, and (3) criteria for waivers of and exemptions from the submissions in electronic format requirements.

Under the process described in this guidance, FDA will periodically issue guidances relating to the submission in electronic format guidelines for certain submission types to the Center for Devices and Radiological Health (CDRH) or the Center for Biologics Evaluation and Research (CBER). These submission types are identified in section III.A of this guidance. FDA believes that issuing this guidance related to submissions solely in an electronic format will harmonize and streamline the process for implementing the various requirements for submission in electronic format under section 745A(b) of the FD&C Act. The process described in this guidance is also intended to provide a meaningful opportunity for the public to comment on guidances that the Agency intends to issue pursuant to section 745A(b) of the FD&C Act.

In section 745A(b)(3) of the FD&C Act, Congress granted explicit statutory authorization to FDA to specify in guidance the electronic submissions requirement by providing standards, criteria for waivers and exemptions, and a timetable for such submissions. Accordingly, to the extent that this document provides such requirements under section 745A(b)(3), indicated by the use of mandatory words, such as must or required, this document is not subject to the usual restrictions in FDA’s good guidance practices (GGPs) regulations, such as the requirement that guidances not establish legally enforceable responsibilities. See 21 CFR 10.115(d).

This document provides guidance on FDA’s interpretation of the statutory requirement for submission in electronic format; however, this document also contains guidance on additional submission types for which submission in electronic format is anticipated to be recommended. Therefore, to the extent that this guidance describes recommendations that are not “standards,” “timetable,” or “criteria for waivers” and “exemptions” under section 745A(b)(3), this document does not create or confer any rights for or on any person and does not operate to bind FDA or the public, but does represent the Agency’s current thinking on this topic. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff listed on the title page of this guidance.

To comply with the GGP regulations and make sure that regulated entities and the public understand that guidance documents are nonbinding, FDA guidances ordinarily contain standard language explaining that guidances should be viewed only as recommendations unless specific regulatory or statutory requirements are cited. FDA is not including this standard language in this guidance because it is not an accurate description of all of the effects of this guidance. This guidance contains both binding and nonbinding provisions. Insofar as this guidance provides “standards,” “timetable,” or “criteria for waivers” and “exemptions” pursuant to section 745A(b) of the FD&C Act, it will have binding effect.

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