Calls For More FDA Training In Lead Up To User-Fee Negotiations
This article was originally published in The Gray Sheet
Device firms will be pushing for more reviewer consistency and to avoid a major increase in fees during upcoming negotiations with FDA to reauthorize the Medical Device User Fee Act. The MDUFA IV reauthorization process starts as Congress is already considering major regulatory reforms and will finish under a new administration in the White House.
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A combined House/Senate "21st Century Cures" package will get a vote in the House on Nov. 30, and soon in the Senate. The medical innovation package includes a breakthrough device pathway that, in its current form, would allow 510(k), as well as PMA and de novo, devices to participate. The bill also provides a modest $500m to help support a range of additional FDA device and drug pathway streamlining reforms. Meanwhile, it would authorize $4.8bn for the Precision Medicine Initiative, a BRAIN Initiative, and for cancer "Moonshot" research funds at NIH.
Here's a snapshot of FDA's current premarket device review activity in seven interactive graphics.
The agency's device center is in the midst of adopting a "Smart" 510(k) template to improve reviewer-to-reviewer consistency and speed up the learning curve for new reviewers. It is part of a broader IT push at the center to further standardize industry submissions and how they are reviewed, the Office of Device Evaluation's Barbara Zimmerman tells "The Gray Sheet."