CDRH Discloses Guidance Priorities For Fiscal 2013
This article was originally published in The Gray Sheet
Executive Summary
The device center has posted its “A-list” and “B-list” of final and draft guidance documents it plans to release this fiscal year; the long-awaited regulatory framework for laboratory-developed tests didn’t make the lists.
You may also be interested in...
510(k) Program, Companion Dx Among Top FDA Guidance Priorities For FY 2014
CDRH says it plans to release the 510(k) program final guidance as well as the anticipated in vitro companion diagnostic final guidance next year. The device center has divided the 22 forthcoming guidance documents into an “A-list” and a “B-list,” based on its priorities and allocated resources.
FDA Charges Ahead With MDUFA III Implementation, Despite Budget Uncertainties
FDA has started carrying out its end of the medical device user fee agreement, with plans to issue several new guidance documents this fall, and the agency suggests that a short-term restriction on full user fee access should not inhibit its efforts.
Final FDA Bill: Device Provisions
Congress has settled on final language for the FDA Safety and Innovation Act. After Senate approval, the bill will go to the White House for President Obama’s signature.