Code Red: The FDA’s Artificial Intelligence/Machine Learning Action Plan Poses Potential Risks for Medical Device Makers
By EsqSocial Corporation 05/02/21
Q: The FDA’s stance on a regulatory framework for artificial intelligence and machine learning (AI/ML) software as a medical device is continuously evolving. Could you explain the history? A: Artificial intelligence (AI) is “adaptive,” meaning that it continuously learns algorithms. For this reason, it is sometimes referred to as Machine Learning (ML). Newly designed medical…...
By: Nutter McClennen & Fish LLP