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www.fdanews.com/articles/90598-u-s-and-japan-implement-program-to-speed-device-approvals

U.S. AND JAPAN IMPLEMENT PROGRAM TO SPEED DEVICE APPROVALS

December 7, 2006

The U.S. and Japan want to remove barriers to timely medical device approvals through the "Harmonization by Doing" (HBD) initiative, aimed at developing common protocols for premarket clinical studies of new cardiovascular technologies.

The pilot project, launched in December 2003 but only now getting under way, is intended to reduce the duplication, added costs and time delays associated with sequential trials and to increase understanding and collaboration between CDRH and Japan's Pharmaceutical and Medical Devices Agency.

The goal of the HBD initiative is to reduce the amount of time it takes for a new therapy that has been shown to be "reasonably safe and effective using global, harmonized protocols conducted in patients worldwide" to become available, the FDA said.

The project will initially focus on drug-eluting stents. However, the agency said it could be expanded to include other cardiovascular devices and device categories, and to address other activities such as postmarket clinical trials and patient registries. The initiative could lead to similar relationships with other countries, the FDA said.

(http://www.fdanews.com/ddl/33_48/)