Independent Assessment Of CDRH Calls For Staff Training, Review Process Improvements-thegraysheet: 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 (PDF) from Booz Allen Hamilton assessing the device center’s review process for device submissions. The Dec. 11 document includes four priority recommendations from Booz Allen, which was contracted by FDA to conduct a two-phase assessment of FDA’s device review program as part of the third medical device user fee agreement (MDUFA III) between industry and FDA, enacted in October 2012.
