Article preview from "The Gray Sheet"- December 11, 2013
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.
Independent Assessment Of CDRH Calls For Staff Training, Review Process Improvements
Article preview from "The Gray Sheet"- December 11, 2013
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 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.
The first, six-month phase of the assessment, which began in June, involved assessing the device submission review processes implemented by FDA as a result of the MDUFA III negotiations, including the refuse to accept, substantive interaction, interactive review and missed MDUFA decision communications. The first phase also included an assessment of FDA’s information technology infrastructure, training and retention policies and practices, and FDA management systems. The contractor will release a full report on findings and recommendations by next June.
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