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

GUIDANCE DOCUMENT

Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Guidance for Industry and FDA Staff May 2005

Final
Docket Number:
FDA-2020-D-0957
Issued by:
Guidance Issuing Office
Office of Medical Products and Tobacco, Center for Devices and Radiological Health

This guidance document is intended to provide information to industry regarding the documentation that we recommend you include in premarket submissions for software devices, including standalone software applications and hardware-based devices that incorporate software. This document is a result of ongoing efforts to state our recommendations more clearly and ensure they remain current as technology advances. This document also combines into one guidance recommendations previously included in two guidance documents.


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-2020-D-0957.