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# Medical Device Review Process Progress in Place: Report
- URL: https://www.fdaweb.com/medical-device-review-process-progress-in-place-report/
- Published: 2019-01-02T12:00:00.000Z
- Updated: 2026-09-15T00:51:22.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143066

An independent Booz Allen report assessing FDA’s medical device review process as required by MDUFA 3 and MDUFA 4 says that CDRH staff are aware of and use the products and resources developed and implemented by the Center for all recommendations the consultants made as part of their initial assessment. The progress [report](https://www.fda.gov/downloads/ForIndustry/UserFees/MedicalDeviceUserFee/UCM628852.pdf?ref=fdaweb.com) says that most of CDRH’s implementation projects met the intent of the recommendations and several have progressed beyond the initial recommendations.

“Overall,” the consultants say, “CDRH’s efforts have been very effective at standardizing CDRH operations, screening staff knowledge to perform submission reviews, increasing regulatory process clarity, and improving decision-making consistency.”

The consultants say that the Center’s actions have positively affected efforts to enhance and improve medical device submission review. The firm also identified additional opportunities, such as enhanced review performance metrics and analytics, better search capabilities within CDRH information technology systems, and implementing resources to facilitate structured electronic submissions that would build on the success of the efforts to increase efficiency and streamline the medical device submission review process.