FDA DEVICE REFORM BILL'S "SCOPE OF REVIEW" CONTROVERSY CAN BE ADDRESSED IN CONFERENCE, SEN. JEFFORDS SAYS; FLOOR VOTE ON PROVISION SLATED FOR SEPT. 23
This article was originally published in The Gray Sheet
Executive Summary
The controversy over the 510(k) "scope of review" provision in the Senate FDA reform/Prescription Drug User Fee Act reauthorization bill (S 830) can be resolved in House-Senate conference and should not delay a vote on the measure, Senate Labor and Human Resources Committee Chairman James Jeffords (R-Vt.) said Sept. 19 during floor debate on the bill.