Collaborative Review Scheme with US FDA and Harmonization By Doing (HBD) Activities Towards Speedier Review of Medical Devices

Abstract

Harmonization By Doing (HBD), whose activities include the exploratory study on the implementation of global clinical trials, consisting of the members from industry, academia and regulators of the United States and Japan, is one of the role models for promoting the development of medical devices. In the coronary area, global clinical trials have been conducted on multiple drug-eluting stents, and the trend to implement global clinical trials on the medical devices is spreading to other cardiovascular areas. Also, faster review of medical devices has become possible, by exchanging information and by discussing the review method with US Food and Drug Administration (FDA), through the pilot program regarding collaborative consultation and review of medical devices for cardiovascular disease, such as superficial femoral artery stent, between Ministry of Health, Labour and Welfare/Pharmaceuticals and Medical Devices Agency (PMDA) and FDA, which was derived from HBD activities. Furthermore, the medical experts and regulators (FDA and PMDA) of the US and Japan have discussed on the basic concept of the global clinical trials for the critical limb ischemia endovascular treatment devices (CLI devices), for which no established evaluation method is available, in order to promote development and to speed up the review. As a result of the discussion, the basic concept of the global clinical trials for CLI devices has been formulated, taking into account the difference of medical environment between the US and Japan, which is expected to be utilized in the future clinical trials and to contribute to the reduction of the review time. We think that it is important to spread the activities for exploring the solutions to the issues in other areas, by having extensive discussion for accelerating the development of medical devices through collaboration with the associated academia and industry.