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GUIDANCE DOCUMENT

Off-The-Shelf Software Use in Medical Devices Guidance for Industry and Food and Drug Administration Staff August 2023

Download the Final Guidance Document
Final
Docket Number:
FDA-2019-D-3598
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

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.

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Submit Comments Online

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-2019-D-3598.

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