FDA: Artificial Intelligence & Machine Learning Action Plan
Tuesday, January 12, 2021 The US Food and Drug Administration (FDA) published an Action Plan for artificial intelligence (AI) and machine learning (ML) software on January 12, 2021 that provides near-term actions to develop a regulatory framework for AI and ML-based medical devices. The quick takeaway is that FDA will publish a draft guidance on change control plans, a key concept from its April 2019 discussion paper on AI/ML-based software devices (previously reported here). F...
Drug Administration Pilot Program For Real Action Plan Public Workshop Publish Draft Guidance Change Control Plan
Source: natlawreview.com