The Senate Health, Education, Labor and Pensions Committee approved a slate of bills Feb. 9, including the Device Accountability Act, which enhances focus on the "least burdensome" concept for device review, and legislation intended to improve oversight of modified devices and device reprocessing.
A Senate panel approved seven medical product reform bills Feb. 9 by unanimous consent, including three that would affect device regulation.
The three device-relevant bills are the Device Accountability Act (S. 1622), the Preventing Superbugs and Protecting Patients Act (S. 2503) and the Improving Health Information Technology Act (S. 2511). The...
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.
