MDUFMA Adjustments Gain Dems’ Support As Congress Heads Toward Recess
This article was originally published in The Gray Sheet
Executive Summary
Sens. Edward Kennedy (D-Mass.) and Judd Gregg (R-N.H.) have reached consensus on the "Medical Device Technical Corrections Act" (S 1881), according to staffers
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Third Party Inspections Await Reconciliation of Technical Corrections Bills
Third-party inspection proponents are hoping that momentum from House passage of the Medical Device User Fee & Modernization Act technical corrections bill will propel enactment within the next few weeks
Third Party Inspections Await Reconciliation of Technical Corrections Bills
Third-party inspection proponents are hoping that momentum from House passage of the Medical Device User Fee & Modernization Act technical corrections bill will propel enactment within the next few weeks
Technical corrections clear Senate
"Medical Device Technical Corrections Act" (S 1881) passes Senate floor vote Nov. 25 by unanimous consent. Sponsored by Sen. Lamar Alexander (R-Tenn.), the bill represents a bipartisan consensus on third-party inspections (1"The Gray Sheet" Nov. 24, 2003, p. 17). The legislation includes an 18-month moratorium on implementation of Sec. 301 of MDUFMA requiring manufacturers to put their name on devices, giving more time for FDA and Congress to weigh potential changes (2"The Gray Sheet" Oct. 27, 2003, In Brief)...