Guidance Document

Electronic Submission Template for Medical Device 510(k) Submissions

Guidance for Industry and Food and Drug Administration Staff

Document issued on October 2, 2023.

Document originally issued on September 22, 2022.

This guidance provides the standards for the submission of premarket notification (510(k)) submissions by electronic format, a timetable for establishment of these standards, and criteria for waivers of and exemptions from the requirements to meet a statutory requirement. This guidance is also 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. As of October 1, 2023, FDA will require that 510(k) electronic submissions be provided as described in this guidance.

Reference: FDA