CARDIOVASCULAR
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Official Publication of the World Artificial Organ, Immunology and Transplantation Society (WAITS)

Volume 10, 2005, No 1

FDA Regulation of Medical Devices – An Overview
C. M. Meyers

In the regulation of medical devices, the role of the United States Food and Drug Administration’s Center for Devices and Radiological Health is to establish reasonable assurance of the safety and effectiveness of medical devices marketed in the United States. The Offices within the Center for Devices and Radiological Health therefore address many aspects involved in the testing, clinical use, and marketing of medical devices. All marketed medical devices are classified in accordance with their level of risk to patients. Requirements for the different medical device premarket submissions to the Food and Drug Administration, either marketing applications or clinical study applications, are largely based upon device classification. The Center for Devices and Radiological Health also addresses postmarket medical device issues that occur after products are marketed for clinical use.

(CVE. 2005; 10 (1): 10-12)

Key words: FDA, CDRH, medical device regulation, premarket notification, premarket approval, investigational device exemption

Catherine M. Meyers, M.D.
National Institutes of Health
National Institute of Diabetes, Digestive and Kidney Diseases
Division of Kidney, Urologic and Hematologic Diseases
Two Democracy Plaza, Suite 641
6707 Democracy Blvd.
Bethesda, MD 20892
USA