Japan-USA orbital atherectomy for calcific coronary lesions: COAST study, a Harmonization by Doing proof-of-concept: The Japanese and US regulatory perspective.

Abstract

Regulatory approval processes for medical devices in Japan and the United States of America (US) often require similar clinical trials to establish safety and effectiveness. The Harmonization by Doing (HBD) program provides a collaborative environment for communication between regulators, academics and industry, facilitating the design and conduct of US/Japanese clinical trials supporting approval in both countries.