FDA U.S. Agent 

(Foreign Establishments)

• Assist in Communications with FDA & Establishment
• Respond to FDA Questions Regarding Establishment's Products
• Assist FDA in Scheduling Establishment Inspections
• Manage FDA Information or Documents on Behalf of the Establishment

FDA Official Correspondent

• Manage Annual Establishment Registration and Device Listings
• Receive Correspondences from the FDA Involving the Owner/Operator and any of the Firm's Establishments
• Updating the Facility Address, Deleting or Activating Device Listings, Adding Initial Importers and Managing the Account through FURLS (FDA’s Unified Registration and Listing System)