Impact of the US election on medical device regulations
While Trump and Robert F Kennedy Jr have named the FDA as a target of particular interest for deregulation efforts, much of the rhetoric surrounds pharmaceutical companies and products.
Regulation
FDA’s final rule on LDTs causes concern, but timeline looks unsteady
WHO updates cervical cancer guidelines to include Roche’s dual-stain test
WHO launches MeDevIS platform to enhance global access to medical devices
New Labour government backs pharma reform in UK
Avicenna.AI secures EU-MDR certification for five AI tools
FDA tags Megadyne paediatric return electrode recall as Class I
FDA tags OptumHealth’s infusion system recall as Class I
