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FDA Proposes Updated Guidance Concerning Cybersecurity of Medical Devices | Jones Day

The U.S. Food and Drug Administration ("FDA") has proposed updated guidance, intended to assist individuals in meeting the cybersecurity requirements for FDA medical device submissions. ....

Human Services , Premarket Cybersecurity Guidance , Medical Devices , Quality System Considerations , Premarket Submissions , Federal Food , Cosmetic Act , Cyber Device ,

FDA Issues Supplemental Draft Guidance for Premarket Cybersecurity | Gardner Law

The U.S. Food and Drug Administration (FDA) recently released its draft guidance with a proposal to add a Section VII. to the Premarket Cybersecurity Guidance to support obligations. ....

Drug Administration , Premarket Cybersecurity Guidance , Cosmetic Act , Medical Devices , Quality System Considerations , Premarket Submissions , Cybersecurity Management Plan ,