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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 the FD&C 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.
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.