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Diving into FDA’s Cybersecurity Expectations

Velentium’s Chris Gates discussed the new medical device cybersecurity laws and regulatory requirements.

MDDI Staff

November 22, 2022

1 Min Read
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Image courtesy of NicoElNino / Alamy Stock Photo

In April, FDA released the latest draft of requirements for cybersecurity in premarket submissions.

Christopher Gates, director of product security at Velentium, discussed the new medical device cybersecurity laws and regulatory requirements and review the new manufacturer's activities expected by FDA during a panel at BioMeDevice Silicon Valley

These activities include the expected 38 cybersecurity deliverables.

Most importantly, Gates spoke about how to add cybersecurity processes to a product’s development lifecycle that will satisfy FDA and secure the medical device system without generating massive cost burdens or development delays.

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