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

On 15 July 2020 the FDA issued the final guidance for industry and FDA staff.

In section 745A(b) of the FD&C Act, Congress granted explicit statutory authorization to the FDA to specify guidance for the electronic submissions requirement by providing standards, criteria for waivers and exemptions, and a timetable for such submissions.

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.