Final Senate MDUFA Package Omits Device Tax Repeal

The Senate voted 96-1 on Thursday to approve an omnibus FDA user fee bill, but earlier in the week rejected including an industry-backed amendment to repeal the upcoming medical device excise tax. The FDA Safety and Innovation Act approved by the Senate, S. 3187, would reauthorize the Medical Device User Fee Act (MDUFA); it also reauthorizes the Prescription Drug User Fee Act and would create new user fee programs for generic drugs and biosimilars.
Devices & Diagnostics Letter