FDA Issues Long-Awaited Guidance On Device Security For Premarket Submissions, Seeks Industry Feedback
The US agency says increasing threats require an updated approach
The US FDA’s 8 April draft guidance on device security replaces the agency’s 2018 guidance on the topic to better meet current cyber challenges.
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Suzanne Schwartz, director of the US FDA’s Office of Strategic Partnerships and Technology Innovation, tells Medtech Insight that recent cyberattacks have crippled hospitals networks, putting many patients at risk.
Draft legislation out of the US Senate Health, Education, Labor and Pensions (HELP) Committee gives the FDA authority to regulate certain in vitro diagnostics known as laboratory developed tests.
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