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Independent Assessment Of CDRH Calls For Staff Training, Review Process Improvements

The priority recommendations from Booz Allen Hamilton, the independent contractor selected to assess CDRH’s review process for device submissions, include improving staff training on information technology systems and adopting a holistic, multipronged approach to standardize reviews.

An independent assessment contracted by CDRH says the center needs to improve the consistency of its device review process and strengthen its training programs.

CDRH published the priority recommendations from Booz Allen Hamilton assessing the device center’s review process for device submissions. The Dec. 11 document includes four priority recommendations from Booz...

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