This webinar is co-hosted by FDA Solutions Group and Sandler, Travis & Rosenberg, an international trade, customs and export law firm.
The Food and Drug Administration requires various parties manufacturing, packing, exporting, and importing medical devices to register the establishment and list its devices with the agency. This registration must be renewed each year between Oct. 1 and Dec. 31. Registration with the FDA (which also involves consenting to an FDA inspection) is a threshold requirement for exporting from an overseas market to the U.S. and importing and selling devices in the U.S. Join us for this complimentary 30-minute webinar reviewing the nuts and bolts of the registration process.Key Topics
- overview of FDA device establishment registration and listing
- dates for registration renewal
- who must register and who is exempt
- what needs to be registered
- where and how to register
- enforcement consequences and best practices