Implementation of a Quality Review Program

CDRH has instituted an ongoing quality review program for premarket submissions to identify and apply best management practices internally. This program is intended to continue to assure we maintain high scientific quality for new treatments and diagnostics as we continue to reduce review times. This is accomplished by ensuring consistency among reviewers and by helping product sponsors submit applications that efficiently demonstrate the safety and effectiveness of the device.


Leveraging Information Technology Solutions

CDRH is undertaking a number of initiatives that leverage the use of information technology (IT) to improve patient safety and make the development process more efficient. We are developing new IT systems that allow for better monitoring and tracking of premarket submissions and for improved communication and coordination among review teams.

Expanding Clinical and Scientific Expertise at FDA

With the additional resources from MDUFMA, CDRH is expanding its use of outside experts through the Medical Device Fellowship Program (MDFP). This expertise will assure that the Center remains current on the latest technological and clinical advances. Over the past two years, CDRH has hired experts in many critical areas, including Anesthesiology, Brachytherapy, Cardiothoracic Surgery, Electrophysiology, Human Factors Engineering, Neurosurgery, Nephrology, Pediatric Cardiology, Pulmonology, Radiation Oncology and Software Engineering. These experts will help FDA expedite the availability of new, cutting edge technology.

These exciting on-going initiatives will build on the successes of MDUFMA and further modernize the medical device review process in order to ultimately improve patient health and safety.

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This draft guidance provides FDA's recommendations on the use of Bayesian statistical methods in the design and analysis of medical device clinical trials. Development of this guidance was influenced by CDRH's unique experience in planning and evaluating Bayesian clinical trials in the regulatory setting. This draft guidance is neither final nor is it in effect at this time. The public can submit written or electronic comments on this draft guidance to Docket No. 2006D-0191 for a period of 90 days, until August 21, 2006.

CDRH will be having a public meeting to address this draft guidance at The Universities of Shady Grove, 9630 Gudelsky Drive, Rockville, MD, from 8:30 - 5:00 on Thursday, July 27, 2006.

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