CFSN Detailed Analysis

FDA Publishes Draft Medical Device Cybersecurity Guidance

Patrick Coyle
Apr 10, 2022
∙ Paid

Yesterday, the FDA published a notice of availability in the Federal Register (87 FR 20878-20875) for a Draft Guidance Document on “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions”. The draft guidance can be downloaded from the Federal eRulemaking Portal.

According to the Summary in the Notice:

“This dr…

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