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U.S. Department of Health and Human Services

Medical Devices

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Collaborative Consultation and Review of Premarketing Applications Pilot Program

June 16, 2011: Announcement and Call for Participation. The Collaborative Consultation and Review of Premarketing Applications Pilot Program, 2011

The U.S. FDA Center for Devices and Radiological Health (CDRH) and Japan Ministry of Health, Labour and Welfare / Pharmaceutical and Medical Devices Agency (MHLW/PMDA) have decided to continue the initiative on sharing information under the "Collaborative Consultation and Review of Premarketing Applications Pilot Program." Initially launched in June 2009, the pilot program is now entering its third year. This announcement is an invitation to U.S. cardiovascular industry to seek nomination of their new device for review and consideration in the pilot program. For more information and details, please read the full FDA Announcement.

June 15, 2010: Collaborative Consultation and Review of Premarketing Applications Pilot Program

An invitation to participate in the 2nd pilot program regarding medical device collaborative consultation and review of premarketing applications (2010).

FDA is encouraging interested sponsors to apply for participation in the second Pilot Program known as the Medical Device Collaborative Consultation and Review of Premarketing Applications. The purpose is to share information between the US FDA (Food and Drug Administration) and Japan MHLW/PMDA (Ministry of Health, Labour and Welfare / Pharmaceuticals and Medical Devices Agency).

June 23, 2009: U.S. - Japan Pilot Program Regarding Medical Device Collaborative Consultation and Review of Premarketing Applications

Japan MHLW/PMDA and U.S. FDA announced this week the launch of a bilateral pilot program on collaborative consultation and review of new cardiovascular devices. The goal of the pilot program is to advance both the speed and quality of clinical/statistical consultations and the regulatory review process for potential earlier market access and improved public health benefit. This collaboration would permit the scientific review staff of both MHLW/PMDA and FDA to discuss the contents of an individual submission in order to gain valuable regulatory information pertaining to device development and clinical trial design.

The Collaborative Scheme is one of several focused topics that will be discussed at the upcoming Japan-US Harmonization By Doing (HBD) West 2009 Meeting, July 16-17 at the FDA White Oak Campus.


Encouraged by global harmonization and moving forward the spirit of regulatory convergence and good communication, a direct consequence of the Japan-US Harmonization By Doing (HBD) program is a new cooperation on information-sharing between the government authorities and industry. The uniqueness of the Medical Device Collaborative Consultation and Review of Premarketing Applications pilot program is the active engagement of the industry sponsor with both US FDA and Japan MHLW/PMDA (Ministry of Health, Labour, and Welfare/Pharmaceuticals and Medical Devices Agency).

A goal of the pilot program is to advance both the speed and quality of clinical/statistical consultations and the regulatory review process for potential earlier market access and improved public health benefit. The collaborative scheme was one of several focused topics discussed at the Japan-US Harmonization By Doing (HBD) West 2009 Meeting, July 16-17 at the FDA White Oak Campus in Silver Spring, Maryland, USA. A copy of the presentation is available at PMDA’s website,

Three-party cooperation begins from pre-submission consultations, continues through the entire review process, and finally to global product approval in both Japan and U.S. markets at about the same time. Confidentiality arrangements exist between US FDA and MHLW and between FDA and PMDA to share non-public information. Furthermore, participation in the pilot study requires sponsors to sign the “Sponsor Authorization for FDA to Share Confidential Commercial Information and/or Trade Secret Information with a Foreign Government or International Organization” (SMG 2830.3 Attachment E of the FDA Staff Manual Guide).

Interested sponsors were encouraged to submit candidate new medical devices under this program and posted on June 15, 2009. MHLW/PMDA and US FDA contacted sponsors on October 27, 2009 by mail in response to their interest for participation in the program. At this time, the pilot program is limited to the cardiovascular industry. Two new cardiovascular devices were selected. It is hoped in the future that that the experience will lead to creation of good regulatory models that could possibly expand the initiative with non-cardiovascular devices and with other countries.