U.S. flag An official website of the United States government
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Content of Premarket Submissions for Device Software Functions
  1. Search for FDA Guidance Documents


Content of Premarket Submissions for Device Software Functions Guidance for Industry and Food and Drug Administration Staff June 2023

Docket Number:
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research
Office of the Commissioner, Office of Clinical Policy and Programs, Office of Combination Products
Center for Drug Evaluation and Research


This guidance document is intended to provide information regarding the recommended documentation for premarket submissions for FDA’s evaluation of the safety and effectiveness of device software functions, which are software functions that meet the definition of a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA recognizes this evolving landscape and seeks to provide our latest thinking on regulatory considerations for device software functions, which considers current standards and best practices. The recommendations in this guidance are intended to facilitate FDA’s premarket review. This guidance document replaces FDA’s Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices issued on May 11, 2005.

Submit Comments

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:

Dockets Management
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-0775.

Back to Top