In this week’s roundup: Bakul Patel exits FDA, and more digital health regulatory updates from the US and China; FDA user fee legislation is introduced in the House; FDA splits IVD and imaging offices, and makes other organizational changes; the US agency escalates actions on Philips CPAP recalls; the EU adds an IVDR notified body and a key guidance document; the IMDRF quietly meets; HHS OIG scrutinizes prior authorization; and more updates from China, Italy, and the US.
It has been a packed week of news and messaging from FDA. We start this week’s roundup with digital health updates, leading with the unexpected departure of digital health expert Bakul Patel from the agency. Also from FDA: notable CDRH organizational updates, the official release of user fee legislation in the House, and discussion coming out of multiple presentations and meetings. Meanwhile, the go-live date for the EU IVD Regulation is about three-weeks away, and there have been several noteworthy developments this week, including a new notified body and a key guidance document. Those items and much more from IMDRF, China, Italy, and the US in this latest edition of Pathways’ Picks.