MDUFA Moves to House Floor, Decision Summaries for Some 510(k)s Likely

An omnibus FDA user fee bill passed last week by the House Energy and Commerce Committee includes a variety of measures aimed at reforming the medical device regulatory process, including a provision requiring the FDA to withdraw its controversial guidance on when manufacturers should submit 510(k)s on modified devices. The Thursday vote came as lawmakers hurried to move the bill toward enactment well before the current iteration of the Medical Device User Fee Act (MDUFA) expires on Sept. 30.
Devices & Diagnostics Letter