FDA Medical Device Facility Registrations and Renewals
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.
This webinar is co-hosted by ST&R and FDA Solutions Group, a regulatory compliance company specializing in the food, beverage, dietary supplement, alcoholic beverage, medical device and cosmetic industries.
- 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
Shelly Garg is an attorney with Sandler, Travis & Rosenberg’s) FDA Practice Group, representing clients across a broad range of FDA-regulated product categories, including food, beverages, dietary supplements, over-the-counter drugs, medical devices, and cosmetics. She advises in strategic business planning, product development, testing and approval, labeling, advertisement and promotion, liability risk, inspections, responding to regulatory enforcement matters, and related issues. Her keen insights into the FDA and its inner workings have proved to be of significant value to her clients in successfully resolving matters before the agency.