Booz Allen: Too Soon To Say If FDA Process Reforms Are Working
This article was originally published in The Gray Sheet
FDA's device center has implemented all the recommendations Booz Allen Hamilton has made in the past several years to improve the review process, the consulting firm said in its latest independent assessment report. But it is still too early to conclude if the changes have led to significant improvements.
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The independent reviewers at Booz Allen Hamilton say US FDA’s device center has not only successfully implemented all 11 recommendations the contractors made as part of the prior user-fee program, but they’ve noticed significant improvements at the center as a result. The reviewers have also added new recommendations in a final report to improve procedures linked to IT systems and staff training.
While there are still a few months to go before the US FDA's Center for Devices and Radiological Health closes its customer service survey, the initial results look to be trending in the agency's favor. With almost nine-in-ten respondents giving a positive review, the results support the agency's efforts to improve customer service.
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new directives that were not included in Booz Allen’s interim report in December: FDA should perform a large study of withdrawn device submissions to figure out how to limit the growing practice.