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GUIDANCE DOCUMENT

Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions Guidance for Industry and Food and Drug Administration Staff September 2023

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2021-D-1158
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This document provides FDA’s recommendations to industry regarding cybersecurity device design, labeling, and the documentation that FDA recommends be included in premarket submissions for devices with cybersecurity risk. These recommendations are intended to promote consistency, facilitate efficient premarket review, and help ensure that marketed medical devices are sufficiently resilient to cybersecurity threats. This document supersedes the final guidance “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices,” issued October 2, 2014.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2021-D-1158.

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