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FDA to Refuse Medical Device Submissions For Cybersecurity Reasons Beginning in October

Jill McKeon, for Health IT Security:

Effective immediately, the US Food and Drug Administration (FDA) will require medical device manufacturers to provide cybersecurity information in their premarket device submissions. Additionally, beginning October 1, the FDA will exercise its authority to refuse submissions for cybersecurity reasons.

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For any submission after March 29, manufacturers must include a “plan to monitor, identify, and address, as appropriate, in a reasonable time, postmarket cybersecurity vulnerabilities and exploits, including coordinated vulnerability disclosure and related procedures,” the FDA stated.

In addition, manufacturers must develop and maintain procedures that provide a reasonable assurance that the device and systems are cybersecure and incorporate plans to patch and update the device and related systems at the postmarket stage.

Lastly, manufacturers are required to provide a software bill of materials (SBOM) for their devices, including commercial, open-source, and off-the-shelf software components. The FDA issued an accompanying FAQ document to help manufacturers determine their obligations.

FDA: Cybersecurity in Medical Devices Frequently Asked Questions (FAQs)