File number:
Issued by:

Guidance Dissemination Office

Center for Devices and Radiation Health

Biologics Evaluation and Research Center

These guidelines provide the additional standards for submitting premarket notification (510(k)) submissions in electronic format, a timeline for establishing these standards, and criteria for waivers and exemptions from the requirements to meet a legal requirement. These guidelines are also intended to represent one of many steps toward fulfilling FDA’s commitment to developing electronic submission templates to serve as guided submission preparation tools for industry to improve consistency. submissions and improve the efficiency of the review process. The FDA identifies October 1, 2023 as the date by which we will require electronic 510(k) submissions to be provided. FDA intends to accept 510(k) submissions recorded on some form of electronic storage medium and sent to FDA if received by FDA by October 1, 2023.

Submit Comments

You may submit online or written comments on any guide at any time (see 21 CFR 10.115(g)(5))

If you cannot submit comments online, please send your written comments to:

Records Management
Food and drug administration
5630 Fisherman’s Lane, Room 1061
Rockville, MD 20852

All written comments should be identified by the file number of this document: FDA-2021-D-0872.