The US FDA released three device-related closeout letters in February, resolving past citations against BioModeling Solutions, Sooil Development Co., and USA Medical LLC. No new warning letters were issued.
Check out Medtech Insight's US FDA Warning Letter Data Tracker here.
This chart lists medical device-related close-out letters posted online by the US Food and Drug Administration in February 2023. The agency's close-out program publicly indicates when a manufacturer has addressed...
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.
