AI-Enabled Tech Faces Dual Hurdles in FDA Regulation, Patent Law

Opinion: Companies developing AI-enabled health-care technologies should treat regulatory and IP strategies as parallel, ...
BioWorld

FDA, IMDRF at loggerheads over scope of PCCP guidances

The International Medical Device Regulators Forum (IMDRF) has issued a draft guidance for predetermined change control plans ...
MobiHealthNews

FDA issues guidance on predetermined change control plan for AI-enabled device software functions

The Food and Drug Administration (FDA) has released guidance providing recommendations on what information should be included in a predetermined change control plan (PCCP) tailored to marketing ...
JD Supra

FDA Issues Guidance on AI for Medical Devices

The Food and Drug Administration (FDA) issued final guidance Monday that explains how medical device manufacturers can use a Predetermined Change Control Plan (PCCP) to update AI-enabled device ...
JD Supra

Keeping up With AI: FDA Issues Guidance on Predetermined Change Control Plans (PCCPs) for Artificial Intelligence (AI)-Enabled Devices

On August 18, 2025, the Food and Drug Administration (FDA) issued guidance (Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device ...