Electronic Submission Template for Medical Device 510(k) Submissions Guidance for Industry and Food and Drug Administration Staff September 2022
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Devices and Radiological HealthCenter for Biologics Evaluation and Research
This guidance provides the further 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. FDA is identifying October 1, 2023 as the date on which we will require that 510(k) electronic submissions be provided. FDA intends to accept 510(k) submissions saved to a form of electronic storage media and mailed to FDA if they are received by FDA before October 1, 2023.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2021-D-0872.