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GUIDANCE DOCUMENT

Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act Draft Guidance for Industry and Food and Drug Administration Staff March 2024

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

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-2021-D-1158

Docket Number:
FDA-2021-D-1158
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research

FDA has developed this draft guidance to propose select updates to the FDA guidance document "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (hereafter referred to as the “Premarket Cybersecurity Guidance"). FDA is proposing to add a Section VII. to the Premarket Cybersecurity Guidance to address new considerations for cyber devices. The new section identifies the cybersecurity information FDA considers to generally be necessary to support obligations under section 524B of the FD&C Act.  The Premarket Cybersecurity Guidance, in its current form, remains the Agency’s current thinking on this topic until this draft guidance is finalized, at which time the finalized version of Section II. of this draft guidance will be added as Section VII. of the Premarket Cybersecurity Guidance.

 
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