FDA Document Details Cyber Expectations for Device Makers

April 7, 2022 CynergisTek, Inc.

The Food and Drug Administration has issued new draft guidance providing updated and detailed recommendations for how medical device makers should address cybersecurity risk in the premarket of their products.

The draft guidance issued Thursday, Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, covers a wide range of cybersecurity device design, labeling and documentation issues - including details about threat modeling, security controls and software bills of materials - that the FDA recommends be addressed by manufacturers in their premarket submissions to the agency.

Mac McMillan discusses the FDA's new guidance and the progress we have made over the last decade in talking about and raising issues with medical device security.

Read the full article here

About the Author

CynergisTek, Inc.

CynergisTek is a top-ranked cybersecurity consulting firm dedicated to serving the information assurance needs of healthcare. CynergisTek offers specialized services and solutions to help organizations achieve privacy, security, and compliance goals. The company has been recognized by KLAS in the 2016 and 2018 Cybersecurity reports as a top performing firm in healthcare cybersecurity, as well as the 2017 Best in KLAS winner for Cybersecurity Advisory Services.

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