AI Health Law & Policy: Complying with FDA GMP rules for AI-enabled diagnostic devices
By EsqSocial Corporation 29/04/25
The U.S. Food and Drug Administration (FDA) recently issued a Warning Letter citing a failure to obtain marketing authorization via a premarket approval (PMA) or 510(k) clearance as well as Good Manufacturing Practice (GMP) violations for an AI-enabled diagnostic medical device. In the letter, FDA provides instructive clarification of its views of the limitations of the 510(k) exemption claimed by the company and also identifies quality management system gaps indicative of a company that has not...
By: Hogan Lovells