Article preview from "The Gray Sheet"- April 30, 2012
Legislation was reported out of committee last week, with some additional amendments under consideration as the user fee reauthorization bill moves closer to the Senate floor. House members still struggle to reach consensus.
Article preview from "The Gray Sheet"- April 30, 2012
Senators are pressing ahead to bring FDA user fee reauthorization and reform legislation to the floor in May following an April 25 approval of a bill by the Senate Health, Education, Labor and Pensions Committee.
The HELP Committee reported out bipartisan legislation
on an 11-1 vote that closely matches previously circulated drafts, with some additions. Discussion of amendments during the markup suggests more changes could come before final passage of the bill.
One amendment, however, that appears to have been taken off the table by committee leaders is a Democratic proposal to prevent companies from using a predicate device that has been recalled due to safety reasons to support a substantially equivalent determination for 510(k) clearance.
Continued...
To read this article in its entirety, Purchase now as a PDF and receive it immediately via email. Or get it FREE when you subscribe to "The Gray Sheet".
Plus:
To find out about more about more about Elsevier Business Intelligence's medical device publications and databases, multi-user access and/or advertising with Medical Devices Today, please contact Kristy Kennedy at (480) 985-9512
Comments