Medical Device Review Processes of U.S. Food and Drug Administration

Abstract

Center for Devices and Radiological Health, one of the 8 Offices of the Food and Drug Administration under Department of Health and Human Services, is in charge of U.S. medical device regulations.In the U.S., medical devices are classified into 3 classes based on its risk. A review pathway, 510(k), is applicable for some Class I devices and most Class II devices. The 510(k) pathway is considered to be flexible and under discussion to introduce in the Japanese regulatory process. The highest risk medical devices classified into Class III are approved through the Premarket Approval (PMA) pathway. Investigational Device Exemption (IDE) is necessary for clinical trials with high-risk medical devices in the U.S. A system of Pre-IDE meeting is very useful for sponsors.FDA may require a Panel Meeting that is similar to the Japanese Senmon Kyogi for a medical device approval. FDA's Panel Meetings are very transparent. The Panel conclusion facilitates FDA's final decision, but not always followed by FDA.Immunity from lawsuits among FDA reviewers is legitimate, although that among Japanese medical device reviewer is not.