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Initial Survey Results Show Overwhelming Satisfaction With FDA Device Center Customer Service

Executive Summary

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.

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CDRH Passes Independent Review With Flying Colors

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.

Booz Allen: Too Soon To Say If FDA Process Reforms Are Working

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.

Shuren On US vs EU: FDA Strikes The Right Regulatory Balance

While the medtech industry has often complained about how much longer it takes to get devices into the US compared with Europe, Jeff Shuren, director of the US FDA's device center thinks the agency has struck the right regulatory balance between public safety and an environment to allow innovation.

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