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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 ....

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FDA Digital Health Notes on Food and Drug Omnibus Reform

Food and Drug Omnibus Reform Act of 2022 FDORA enacted on December 29, 2022 as part of larger Consolidated Appropriations Act for 2023. Future reforms medical product developers, review last year actions policy updates on digital health from Food and Drug Administration. ....

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