Could a new FDA regulatory approach for postmarket changes to artificial intelligence (AI)/machine learning (ML)–based software devices be in our future? A recent discussion paper offers important insight into the FDA’s thinking on reducing postmarket burdens for FDA cleared or approved AI/ML technologies. Given that the FDA has yet to develop clear guidance on when AI/ML technologies are subject to regulation, could the FDA’s proposal to address postmarket changes for these technologies be putting the cart before the horse?
Read the full LawFlash for more in-depth analysis on FDA’s discussion paper.