New FDA Medical Device Cybersecurity Guidance Emphasizes Design

By Jessica Karins / September 27, 2023 at 1:26 PM
FDA released final guidance on the cybersecurity design, labeling and documentation that should be included when submitting medical devices for premarket review to the agency. Telehealth and device industry stakeholders, who had raised concerns new requirements for connected devices could be burdensome and cyber vulnerabilities might not be reported to providers, can get more information at an FDA webinar Nov. 2. The guidance , released Wednesday (Sept. 27), emphasizes how medical device cybersecurity is a pressing issue for the health...

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