Guidance Document
Content of Premarket Submissions for Device Software Functions
Guidance for Industry and Food and Drug Administration Staff
Document issued on June 14, 2023.
The draft of this document was issued on November 4, 2021.
This document supersedes Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 2005.
Docket Number: FDA-2021-D-0775
Issued by:
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.
Download the Final Guidance DocumentsReference: FDA
