Senate HELP Ranking Member Sen. Patty Murray in a staff report criticizes FDA and manufacturers for reacting slowly to duodenoscope contamination incidents in 2013. The report says FDA needs a more robust device surveillance system and calls for more attention to 510(k) modification policies. Murray is a key partner in ongoing Senate work to produce a so-called "medical innovation" bill.
Sen. Patty Murray, D-Wash., is calling for a series of reforms to device postmarket surveillance and 510(k) modification policies, and also a phased-in recall of closed-channel duodenoscopes, following her release of an investigative report on contaminated scopes.
The report, issued by the Senate Health, Education, Labor and Pensions Committee minority staff, squarely blames duodenoscope makers Olympus America, Inc., Fujifilm Medical Systems USA Inc. and Hoya...
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.
