Medical Device Establishment Registration and Device Listing Requirements Checklist

Summary

This checklist covers requirements and key steps for facilities to register with the U.S. Food and Drug Administration (FDA) as medical device establishments and to satisfy the FDA's medical device listing requirements. All domestic and foreign establishments involved in the manufacture of medical devices for commercial sale in the U.S. must register with the FDA. Also, most facilities that are required to register with the FDA must list the devices with the FDA along with the manufacturing activities performed on them at the facility. Failure to register and list may render a device misbranded, adulterated, or both. In addition, failure to register a facility and list a medical device could lead to medical devices being denied entry into the U.S. and further regulatory action against the device establishment.