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Cybersecurity Guide Makeover for Medical Devices Pitched by FDA

April 7, 2022, 5:53 PM

Medical device makers should use established security frameworks to reduce vulnerabilities during the regulatory process according to new FDA guidance aimed at combating an increase in digital attacks.

Manufacturers have until July 7 to weigh in on the FDA’s proposed guidelines for developing secure devices equipped to handle modern cyber attacks. Laying out recommendations for premarket submissions, the draft replaces a 2018 guidance document and adds exemptions for investigational devices and clarifies document requests, the agency said in a Thursday Federal Register notice.

Upon agency adoption, the guidance will offer a modernized approach for device makers navigating security vulnerabilities while ...