FDA Releases Discussion Paper on Medical Device Cybersecurity Challenges

The U.S. Food and Drug Administration (FDA) has released a discussion paper on specific cybersecurity practices related to the servicing of medical devices.

The discussion paper, “Strengthening Cybersecurity Practices Associated with Servicing of Medical Devices: Challenges and Opportunities,” considers cybersecurity issues that are unique to the repair or routine maintenance servicing of a finished medical device. Specific cybersecurity aspects addressed in the paper include 1) privileged access; 2) identification of cybersecurity vulnerabilities and incidents; 3) prevention and mitigation of cybersecurity vulnerabilities; and 4) product lifecycle challenges and opportunities.

The paper is part of the FDA’s “total product lifecycle (TPLC)” approach to strengthening the overall cybersecurity of medical devices.

Read the FDA’s discussion paper on cybersecurity practices for the servicing of medical devices. Stakeholder comments on the discussion paper can be made until September 22 through the Regulations.gov website (reference Docket ID FDA-2021-N-0561).

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