New medical device policy provisions can be expected by the end of September 2012:
Key Senators Eye Supply Chain, Device Add-Ons To Upcoming FDA User Fee Bill - Inside Health Policy: "The top Democrat and Republican on the Senate health panel signaled Wednesday (July 27) that they intend to add various new policy provisions to a likely omnibus drug and medical device user fee bill set for passage by the end of September next year, floating possible changes to the supply chain and device reviews as add-on options. Sens. Tom Harkin (D-IA) and Mike Enzi (R-WY) -- chair and ranking member of the health committee, respectively -- said they would work on a bipartisan basis to reauthorize FDA drug and medical device user fees, along with establishing new user fees for generic pharmaceuticals and products in the health reform-created biosimilars pathway."
