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Big Uptick In Withdrawn 510(k)s Highlighted In Booz Allen Assessment

This article was originally published in The Gray Sheet

Executive Summary

The consulting group issued its final assessment of FDA’s device review program following a year-long examination; it includes 11 recommendations for improvements. Among the new directives that were not included in Booz Allen’s interim report in December: FDA should perform a large study of withdrawn device submissions to figure out how to limit the growing practice.

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