Issue Date: August 11, 2023
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket, Digital Health
Status: Final
Off-The-Shelf Software Use in Medical Devices: Guidance for Industry and Food and Drug Administration Staff
This guidance document provides information regarding the recommended documentation sponsors should include in a premarket submission for FDA’s evaluation of off-the-shelf (OTS) software used in a medical device. This guidance describes information that would be typically generated and documented during software development, verification, and validation. The recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of OTS software used in a medical device.
Download the Guidance Document
