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U.S. Department of Health and Human Services

Medical Devices

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Letter From Center Director: Pilot Program Selection Results

March 10, 2010

To: U.S. Cardiovascular Industry

From: Dr. Jeffrey E. Shuren, Director, Center for Devices and Radiological Health (CDRH), U.S. Food and Drug Administration (FDA)

Selection Results for the Pilot Program on Sharing Information Between the US FDA and Japan MHLW/PMDA (Ministry of Health, Labour and Welfare / Pharmaceuticals and Medical Devices Agency) Regarding Medical Device Collaborative Consultation and Review of Premarketing Applications.

On October 27, 2009, MHLW/PMDA and FDA recently contacted sponsors who have submitted proposals for participation in the “Pilot Program on Sharing Information between the US FDA and Japan MHLW/PMDA Regarding Medical Device Collaborative Consultation and Review of Premarketing Applications,” which had been announced on June 15, 2009. A summary of the selection process and results, in addition to future procedures for applicants, are as follows:

1. Selection Process

MHLW/PMDA and FDA jointly selected 2 medical devices from 9 candidate proposals, submitted by one Japanese sponsor and one US sponsor. Consideration was given to the public health benefit and the novelty of the device, as well as the balance of the selection process between Japan and the US, with the goal of acquiring invaluable experience through this pilot program. The selection decisions were independent of potential regulatory decisions, such as the approvability of the candidate devices.

2. Future Procedures for Selected Medical Devices

A participating sponsor may withdraw from the pilot program at any time, and is free to pursue the normal regulatory process in each agency individually. MHLW/PMDA and FDA also may discontinue the pilot program for a specific device. Should this occur, an alternative device may be selected from candidate proposals that were not initially selected for participation in this pilot program.

3. Future Procedures for Other Candidate Medical Devices That Have Not Been Selected

MHLW/PMDA and FDA will grant a one-time, one-topic, three-way discussion to share information between FDA and MHLW/PMDA for each candidate device that was not selected for participation in this pilot program, within one year of notification if the sponsor of the device desires and requests such an interaction.

For inquiries, please contact Ms. Carole C. Carey, Director, International Relations and External Affairs Staff Medical Devices at 301-796-5708 or carole.carey@fda.hhs.gov.