Raising the Bar on Premarket Medical Device Cybersecurity
Dr. Suzanne Schwartz of the FDA Discusses Agency's New Draft Guidance
April 25, 2022
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About this episode
The Food and Drug Administration's decision to incorporate "quality systems regulations" into its new draft guidance for premarket medical device cybersecurity is an important development in the scope of the agency's expectations for manufacturers, says Dr. Suzanne Schwartz of the FDA.