Finalized Cybersecurity Guidance Covers FDORA Mandates, Adds Quality System and TPLC Recommendations

Dennis Tosh
September 27, 2023 at 04:26 PM EST
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The FDA has issued an important update of its October 2014 guidance on cybersecurity assurances that medical device manufacturers should include in their premarket submissions to the agency. The new guidance, intended to address the heightened level of risk posed by the increased interconnectivity of devices, also covers cybersecurity considerations that device firms should ad... Read More