TECHNOLOGY-ASSESSMENT OF MEDICAL DEVICES AT THE CENTER FOR DEVICES AND RADIOLOGICAL HEALTH

We reviewed the Food and Drug Administration's regulatory process for medical devices and described the issues that arise in assessing devic e safety and effectiveness during the postmarket period. The Center fo r Devices and Radiological Health (CDRH), an organization within the F ood and Drug Administration, has the legal authority and responsibilit y for ensuring that medical devices marketed in the United States are both reasonably safe and effective for their intended use. This is an enormous challenge given the diversity of medical devices and the larg e number of different types of devices on the market. Many scientific and regulatory activities are necessary to ensure device safety and ef fectiveness, including technology assessment, albeit in a manner quite different from that of conventional technology assessment. The basic approach taken at the CDRH to ensure device safety and effectiveness i s to develop an understanding of the way in which a medical device wor ks and how it will perform in clinical situations.