Regulatory Submissions for Medical Devices

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

Guidance for Industry and Food and Drug Administration Staff

July 15, 2020

The US Food and Drug Administration (FDA or the Agency) has issued final guidance entitled “Providing Regulatory Submissions for Medical Devices in Electronic Format – Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act.” This final guidance supersedes draft guidance issued on September 26, 2019.  

The law* 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 the FD&C 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.

*: The law refers to 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. 115-52). 

FDA will issue a draft and then final guidance document on the use of the electronic submission templates. 

The Agency has determined 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.

This document provides guidance on FDA’s interpretation of the statutory requirement for submission in electronic format; 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. 

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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Last Updated: 2020-07-15

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