Proposed Final Document: Guidance on Pre-market submission requirement for artificial intelligence/machine learning based computer-assisted detection (CADe) and computer-assisted diagnosis (CADx) software as a medical device

After the receipt of comments from members and the review by the GHWP leadership, the Proposed Final Document: Guidance on Pre-market submission requirement for artificial intelligence/machine learning based computer-assisted detection (CADe) and computer-assisted diagnosis (CADx) software as a medical device will be proceeded for endorsement at The GHWP 29th Annual Meeting.