The agency's Digital Health Advisory Committee will meet on November 6 and focus on how these digital tools could help ...

The FDA will convene experts on Nov. 6 to discuss challenges around regulating mental health products that use artificial ...

Dr. Erik Langhoff, chief medical officer and consultant for the Bronx Regional Health Information Organization, discusses how ...

The FDA’s firm-based approach to regulating medical devices means that the regulatory oversight focuses on the quality systems and processes of the manufacturing firm, rather than just on the ...

Commenters to the FDA also advocated for safety reforms and for industry funds to be used for post-market monitoring.

When the Federal Drug Administration (FDA) updated the provisions for medical device cybersecurity, one of those required the development of a software bill of materials (SBOM). It’s now mandatory for ...

Advisory committee meetings help FDA scientists make decisions and increase public understanding of drug regulation, and ...