ARTICLE SUMMARY:
In this week’s roundup: The UK’s director of devices has left to join notified body BSI, EU issues proposed rule on regulating devices “without an intended medical purpose,” FDA has more than 900 comments to review on its OTC hearing aids draft regulation, the agency issues a strategy report to better address the health of women, the AMA launches a CPT program for health tech developers, and Robert Califf’s commissioner nomination process has ups and downs.
Europe Picks
UK turnover and MDR draft rule:
UK device chief leaves for BSI. Graeme Tunbridge left the UK Medicines and Healthcare products Regulation Agency (MHRA) this month to take a post heading medical device regulatory operations at notified body BSI. Tunbridge, who has been a part of UK healthcare and medtech policymaking for the past 17 years, served as MHRA’s director of devices since 2019, leading the agency’s ongoing efforts to transition to an independent device/IVD oversight structure in the wake of Brexit.
