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Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act Draft Guidance for Industry and Food and Drug Administration Staff March 2024
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
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All written comments should be identified with this document's docket number: FDA-2021-D-1158
- Docket Number:
- FDA-2021-D-1158
- Issued by:
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Guidance Issuing OfficeCenter for Devices and Radiological HealthCenter 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FDA has developed this draft guidance to propose select updates to the FDA guidance document "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions”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Premarket Cybersecurity Guidance, in its current form, remains the Agency’s current thinking on this topic until this draft guidance is finalized, at which time the finalized version of Section II. of this draft guidance will be added as Section VII.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.