Electronic Submission Template for Medical Device 510(k) Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability

Issuing agencies

Abstract

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Electronic Submission Template for Medical Device 510(k) Submissions." This final guidance is intended to represent one of several steps in meeting FDA's commitment to the development of electronic submission templates to serve as guided submission preparation tools for industry to improve submission consistency and enhance efficiency in the review process. This guidance document 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.