June 12, 2014 by Brad Perriello
The FDA details its plan to refine processes at the Center for Devices & Radiological Health, in response to an outside consultant’s audit that found inconsistencies across the watchdog agency’s medical device evaluation procedures.
The FDA yesterday detailed a plan to overhaul procedures at its medical device arm, the Center for Devices & Radiological Health, based on recommendations from an outside auditor’s report last year.
The FDA said it will implement a 2-stage process to address the 4 main recommendations of the report consultants Booz Allen Hamilton issued late last year. If the FDA wants to meet the promises it made during the latest round of medtech user fee negotiations, the firm advised, it needs to establish more consistency in decision-making, ramp up its training programs and address quality management issues to make the review process more transparent and standardized for reviewers and the companies undergoing review.