Clinical Trials on Medical Devices

Abstract

While valid scientific investigations of new drugs have long been sponsored by health care companies, the complexities of high-technology clinical devices has required a re-thinking of the entire process of clinical trials on medical devices. The basic development process will be reviewed and the differences from drug clinical trials will be emphasized. Regulatory classifications of various medical devices are listed, along with the regulatory issues they represent. Clinical and practical issues of doing a trial on devices will be discussed. Specific examples (design issues, monitoring, data collection and verification, analysis and reporting) of studies on both low-and high-technology products will be presented. Regulatory obligations of clinical investigators will be mentioned.