The U.S. Food and Drug Administration (FDA or the Agency) has issued guidance concerning cybersecurity requirements for certain medical device premarket submissions (the Guidance). The.
FDA published guidance on cybersecurity requirements for certain device premarket submissions outlining implementation of new Section 524B of Federal Food, Drug, and Cosmetic Act FDCA. Manufacturers must meet cybersecurity requirements.
On March 29, 2023, and March 30, 2023, the U.S. Food & Drug Administration (“FDA”) issued a series of FAQs and a guidance document clarifying the agency’s intended implementation of the.
Guidance documents from FDA clarifying agency implementation of Consolidated Appropriations Act that amended Section 524B of the Food Drug and Cosmetics Act to require the demonstration of cybersecurity safeguards in pre market submissions for certain medical devices.