New US FDA draft guidance on 510(k)s for peripheral vascular atherectomy devices asks sponsors to submit clinical trial data due to lack of a good animal model.
US FDA issued a draft guidance document July 27 for peripheral vascular atherectomy devices, asking sponsors submit clinical evidence to help prove the new devices are substantially equivalent to their predicates.
While clinical trial data is not requested for a majority of 510(k) devices, clinical data in about 10% to 15% of cases, according to FDA.
The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.
Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.
Fujirebio Diagnostics' Alzheimer's disease test, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, has been cleared by the US FDA.
