Aphelion Consultants LLC - Comment

The is a Comment on the Food and Drug Administration (FDA) Notice: Medical Device User Fee Act Public Meeting

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FDA has proposed an "Independent Assessment of Review Process Management" with the MDUFA.

FDA will award a contract to a private, independent consulting firm that will publish findings on high-priority recommendations within 6 months of the contract award, and will publish its final comprehensive findings and recommendations within 1 year of the contract award. FDA will publish an implementation plan within six months of receipt of each set of recommendations, and will then incorporate the findings and recommendations into its management of the premarket review program.

Though on its face it seems like a good idea to have a third party assess the review process management, this idea is not completely dissimilar from FDA’s contract with the Institute of Medicine (“IOM”) to review the 510(k) program and provide recommendations.

It is not clear that FDA has, at this time, implemented any of the recommendations provided by the IOM, and there is no guarantee that it will act differently with regard to the third party recommendations. Hiring a consulting group certainly will not have any short-term beneficial impact. While an outside assessment may be valuable, there are many ways in which this can become an exercise in generating a report that gets lots of attention but has no impact on actual practices.

The draft proposals appear intended to address several of the key concerns raised by industry about premarket review. As with all FDA proposals, only time will tell whether FDA will follow its own recommendations, and, if so, whether implementation of those recommendations will have the desired results.

Aphelion Consultants has received many opinions from our clients in industry that "Independent Assessment of Review Process Management" should be given some input from within industry as well.
Comment Period Closed
Apr 16 2012, at 11:59 PM ET
ID: FDA-2010-N-0389-0022
Tracking Number: 80fecdb3

Document Information

Date Posted: Apr 12, 2012
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Submitter Information

Country: United States
State or Province: FL
Submitter's Representative: Jonathan Mitchell
Category: Drug Association - D0012