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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...

Multiple policy documents relating to software and digital health have been issued by the U.S. Food and Drug Administration (FDA). The documents offer: a framework for the use of...

In recent days, the U.S. Food and Drug Administration (FDA) has issued multiple policy documents relating to software and digital health. Two of them relate to software-based medical...

/PRNewswire/ --Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: This week, the FDA approved...

The FDA intends to start rejecting medical devices for cybersecurity reasons in October, but new submissions must include plans beginning March 29.

On October 17, 2022, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) released the list of guidance documents proposed for publication in...