Devices

Industry Outlines Overall MDUFA 5 Proposal

During the 4/28 MDUFA 5 user fee negotiating session, industry representatives presented their overall proposal for the MDUFA 5 package. Just-released minutes of the session say the industry first confirmed its principles for the user fee program:

supporting timely patient access to safe and effective medical devices and maintaining the U.S. review process as the gold standard in the world for patient safety;
congressional appropriations remain the primary source of CDRH funding, with user fees as additive;
user fees are solely for premarket review, while industry actively supports additional general appropriations for patient safety and patient engagement issues;
recognition that industry has made significant and material investments in building the program through MDUFA 1-4; and
user fees should support mutually shared goals and process improvements to help achieve timely patient access to safe and effective devices.

The industry proposal contains eight elements described in the minutes.

During the negotiating session FDA provided an update on how CDRH is addressing the impact of the Covid-19 workload on “conventional premarket submission review; presented a proposal for enhancing post-market medical device safety; presented additional data to support its proposal for the TPLC advisory program, and reiterated its goals for MDUFA reauthorization and presented a roadmap of key topics to address its goals.

The agency said it would consider the industry proposals and initially noted significant concerns with some of the industry proposals relating to MDUFA finances, particularly the expectation of a negative response from FDA leadership to the proposal to reinstate or expand the fifth year offset in fees, given the negative effects that had caused FDA to seek and industry to support discontinuing the offset provision as part of MDUFA 4. Industry indicated its expectation that ending the fifth year offset meant that fees above the baseline would be reinvested in the program in areas of mutual interest to FDA and industry.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome