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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...
Our latest briefing dives into new local laws about AI and how it affects both employment and insurance industries, the launch of NIST’s Trustworthy & Responsible Artificial...
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.
The U.S. Food and Drug Administration (FDA) has issued new guidance to the medical device industry on the importance of cybersecurity measures in product development.
Channeling Men Without Hats’ 1982 catchy (not classic) hit, “Safety Dance,” FDA told industry in a recently issued guidance that medical device companies could submit marketing...