MDUFA Clears Senate HELP Committee, House Reschedules Markup for May 8

A Senate health committee approved its version of an omnibus FDA user fee bill Wednesday, sending it to the Senate floor for a vote as early as next month. The bill would permit the FDA commissioner to bypass the regulatory review process and reclassify devices by administrative order. A proposal by Sen. Orrin Hatch (R-Utah) to limit these to down-classifications of devices was withdrawn.
Devices & Diagnostics Letter