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MedISAO Launches AI-Powered Vulnerability Analysis to Address National Vulnerability Database Disruptions

MedISAO Launches AI-Powered Vulnerability Analysis to Address National Vulnerability Database Disruptions
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U S Food and Drug Administration (FDA) Extends its Memorandum of Understanding (MOU) with MedISAO

Strategic partnership between FDA and MedISAO emphasizes the importance of strengthening medical device security

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Medical Device Developers Now Required To Incorporate Cybersecurity Plans Into FDA Premarket Submissions For

Regular readers of our Mintz Viewpoints will likely remember that the Consolidated Appropriations Act for 2023, signed into law by President Biden on December 29, 2022.

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Cybersecurity Requirements for Medical Device Developers FDA

FDORA requires developers of cyber devices plan to monitor cybersecurity vulnerabilities of marketed devices and submit plans to FDA as part of product application. Amended law defines cyber device as software connecting to internet and containing technological features

Device centerDrug administrationMintz viewpointsConsolidated appropriations actPresident bidenDrug omnibus reform actPremarket submissionsMedical devicesPostmarket managementFederal foodCosmetic actMedical device developersYbersecurity plans fda premarket submissionsOod and drug omnibus reform act

Medical Device Developers Now Required to Incorporate Cybersecurity Plans into FDA Premarket Submissions for Cyber Devices | Mintz - Health Care Viewpoints

Regular readers of our Mintz Viewpoints will likely remember that the Consolidated Appropriations Act for 2023, signed into law by President Biden on December 29, 2022, included as one.

Drug administrationDevice centerMintz viewpointsConsolidated appropriations actPresident bidenDrug omnibus reform actPremarket submissionsMedical devicesPostmarket managementFederal foodCosmetic act

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