Issue Date: May 29, 2025
Issued by: Center for Devices and Radiological Health
Topic(s):
Status: Draft
Electronic Submission Template for Medical Device Q-Submissions: Draft Guidance for Industry and Food and Drug Administration Staff
FDA is issuing this draft guidance document to introduce submitters of certain Q-Submissions (Q-Subs), specifically Pre-Submissions (Pre-Subs), to the Center for Devices and Radiological Health and Center for Biologics Evaluation and Research to the current resources and associated content developed and made publicly available to support Pre-Sub electronic submissions to FDA. This draft guidance is intended to represent one of several steps in meeting FDA’s commitment to the development of electronic submission templates to serve as guided submission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. When finalized, this guidance will provide standards for the submission by electronic format, a timetable for when the FDA intends to require Pre-Subs to be provided in electronic format, and criteria for waivers of and exemptions from the requirements.
Download the Guidance Document
