President Cites “Faulty Medical Devices” In State Of The Union
This article was originally published in The Gray Sheet
Executive Summary
State of The Union address references “faulty medical devices” with financial fraud and toxic dumping as things in need of smart regulation. The policy significance, if any, is unknown, but the subtext appears to be a subtle shift from mentions of the industry by the president in 2011.
You may also be interested in...
Markey Bill Would Bar 510(k) Clearances Of Devices With Recalled Predicates
Sponsors say the bill “closes a significant loophole that currently puts patients at serious risk of debilitating injury by ensuring that devices do not mimic the mistakes made by other products.”
News In Brief
Industry guides on ethical distribution pacts. Stryker settles charges over OP-1 marketing. Terumo buys Onset Medical. More news briefs.
FDA, Industry Haggle Over Price For New User Fee Deal
As of last month, FDA and industry were several hundred million dollars apart, according to recently released negotiation meeting minutes. And insiders suggest the two are still haggling over the total amount companies will need to shell out in the five-year user fee reauthorization.