The FDA needs to make some quality and consistency improvements to meet the promises it made during the latest round of medtech user fee negotiations, according to a team of Booz Allen Hamilton consultants evaluating the FDA’s medical device regulatory review program. The consultants asked the FDA 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.
Booz Allen (which just happens to be the former employer of NSA secrets leaker Edwards Snowden) laid out a series of recommendations to get the FDA on track, including more extensive training and training assessment programs to get reviewers up to speed on new guidances and IT systems and to evaluate the outcomes of training in terms of reviewer behavior and satisfaction.
The consultants highlighted in particular industry complaints that there was little transparency or consistency in the review process.
REFERENCE: Mass Device; December 12, 2013; Arezu Sarvestani