SMEDTEC Intelligence

Eight must-read updates: FDA classifies STI home-collection diagnostics & infant pulse-ox OTC; MHRA backs AI continuous oversight with new Airlock phase; 510(k) exemptions for toxicology test systems; and more.

UK's National Commission on AI in Healthcare drops landmark recommendations; FDA finalises Class II status for cardiovascular ML software and eight other device types; MHRA Manchester sandbox launches — all in this fortnight's digest.

MHRA reform amendments tabled in UK Health Bill, cobalt-chrome hip safety signal, Boston Scientific cyberattack, FDA recognised standards update, Health Canada SAP changes — your fortnightly regulatory briefing.

FDA finalises ISH oncology test downclassification; MHRA orders quarantine of non-conforming devices; infant rectal catheter ban; DBT & cystoscope reclassification proposals; MHRA fee consultation — all in this issue.

Eight must-reads: new FDA Class II designations, MHRA's ambient voice & digital health device guidance, FY2027 user fee rates, UK clinical investigation updates, and a UK anaesthesia workstation safety alert.

MHRA sets economic growth targets, updates approved-body list and custom-device guidance; MDUFA VI draft signals FDA review changes from 2028; plus UK field safety notices and key recalls.

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.