SMEDTEC Intelligence

FDA quietly pulls 30+ consensus standards from its recognition database — check your 510(k)/PMA submissions now. Plus: MDUFA V consultation opens, MHRA secures fraud convictions, and MR-safety labelling standard derecognised.

FDA finalises Class II classifications across 10+ device types; MHRA refreshes Innovation Accelerator and borderline-product guidance; key UK Field Safety Notices published.

FDA classifies 10+ device types under Class II special controls; MHRA refreshes innovation support offering; Whoop warning letter closed — all the regulatory moves you need to track this fortnight.