Home » MDUFA Passes Final House Vote With Few Changes to Device Provisions
MDUFA Passes Final House Vote With Few Changes to Device Provisions
The House Wednesday overwhelmingly approved reauthorizing the Medical Device User Fee Act (MDUFA), sending it on to the Senate with a voice vote. The reconciled version of the bill, the FDA Safety and Innovation Act, S. 3187, was ironed out between Senate and House negotiators June 18. Among other measures, it voids recent draft FDA guidance on 510(k) submissions for device modifications and does away with an earlier Senate provision that would have required the agency to get stakeholder input before issuing guidance on mobile health apps.
Devices & Diagnostics Letter
Devices & Diagnostics Letter
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