ARTICLE SUMMARY:
In this week’s Pathways Picks: Top FDA officials meet with UK counterparts in London and more medtech updates from the United Kingdom; William Maisel announces plans to retire from FDA after 14 years as a top CDRH official; FDA warns of fraudulent and unreliable device test data; and more from Europe, China, and the US.
UK Picks
A big medtech week in Britain with an FDA visit, innovative device annoucement, and more:
FDA in London. Commissioner Robert Califf and an FDA contingent visited London this week to meet with counterparts at the UK Medicines and Healthcare products Regulatory Agency (MHRA), as well as researchers and industry representatives. The topics of discussion were broad-based, but medical device issues were in the mix, in particular AI and other medical software. In conjunction with the visit, FDA’s international office published an interview with MHRA CEO June Raine where she highlighted AI and software as one of the top three priorities for global regulators. Raines also emphasized a focus on international convergence in device regulation. In less than a month, MHRA device officials will be making their way across the Atlantic for the International Medical Device Regulators Forum’s upcoming biannual meeting. FDA will host the meeting as 2024 chair of IMDRF in Washington, DC, March 11-15.
