ARTICLE SUMMARY:
In the latest roundup: FDA’s new digital health center and closely watched “intended use” proposed rule; global updates from this week’s International Medical Device Regulators Forum meeting; CMS payment models; HHS controversy; and more.
FDA launched its long-anticipated digital health center and made a new attempt at clarifying what constitutes a company’s “intended use” of a product. There were also some interesting global regulatory updates that came out of this week’s IMDRF virtual meet-up, as detailed in this latest edition of Pathways’ Picks.
