eSTAR Challenges, Focal Point Programs, and More Nuggets From an FDA Independent Assessment

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Contractor Booz Allen Hamilton delivered its latest independent assessment of FDA’s device review program. Here are four under-the-radar findings that caught our attention.

It has become a routine for FDA to disclose results of an independent assessment by Booz Allen Hamilton of its device review program every few years due to commitments the agency has made under the last two user-fee agreements. The Washington, DC-area consulting firm, which FDA has contracted to perform the CDRH reviews since 2013, delivered its latest independent assessment report September 30, giving high-marks to FDA on meeting its commitments.

FDA bills the report as the final one under the MDUFA IV user fee program, which expires next September. Of all the top-line obligations in FDA’s MDUFA IV commitment letter, the contractor says the agency has met all but one—failing to deliver an updated draft guidance on “Content of Premarket Submissions for Software Contained in Medical Devices.” FDA says that document should be out by the end of the year. In any case, getting behind on one guidance doesn’t seem like much of an issue considering the unprecedented burdens of the COVID-19 pandemic the agency has recently faced.

But beyond the top-line evaluation, the independent assessment is chock-full of updates and tidbits about FDA’s device program. Here are four under-the-radar points that caught our eye:


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