FDA US Agent for Foreign Medical Device Establishments
Every foreign establishment that manufactures, prepares, propagates, compounds or processes a medical device imported into the United States must register with FDA, list its devices, and designate a single U.S. Agent. Registration is renewed every year between October 1 and December 31, and FDA's annual establishment fee must be paid first.
Who needs a U.S. Agent
- Foreign manufacturers, contract manufacturers, contract sterilizers, specification developers, repackagers, relabelers and some kit assemblers of devices exported to the U.S.
- Initial importers in the U.S. register separately; they do not need a U.S. Agent
Deadlines
- Register within 30 days of beginning an operation that requires registration
- Renew annually between October 1 and December 31 (21 CFR 807.22)
- Pay the annual establishment registration user fee before submitting
Steps to register
- Pay FDA's annual establishment registration fee through the Device Facility User Fee website and get a Payment Identification Number
- Create an account in FDA's FURLS Device Registration and Listing Module (DRLM)
- Your official correspondent enters the establishment, owner/operator, U.S. Agent and device listings
- FDA emails the U.S. Agent to confirm the designation
- Keep your FEI and owner/operator number on file
US Agent Desk prepares this data for your officer and serves as your U.S. Agent. Your company's own officer submits the registration in FDA's system.
Common mistakes
- Paying the user fee but never completing the registration in DRLM
- Naming a U.S. Agent who has not agreed. The agent must confirm in FDA's system
- Forgetting to list each device under the correct product code
- Believing that registration means FDA has cleared or approved the device. It does not
By country
Medical device establishment U.S. Agent for China · Medical device establishment U.S. Agent for India · Medical device establishment U.S. Agent for South Korea · Medical device establishment U.S. Agent for Japan · Medical device establishment U.S. Agent for Vietnam · Medical device establishment U.S. Agent for Taiwan · Medical device establishment U.S. Agent for Mexico · Medical device establishment U.S. Agent for Italy · Medical device establishment U.S. Agent for Germany · Medical device establishment U.S. Agent for France · Medical device establishment U.S. Agent for Spain · Medical device establishment U.S. Agent for Turkey · Medical device establishment U.S. Agent for Thailand · Medical device establishment U.S. Agent for Indonesia · Medical device establishment U.S. Agent for Brazil · Medical device establishment U.S. Agent for Canada · Medical device establishment U.S. Agent for United Kingdom · Medical device establishment U.S. Agent for Israel · Medical device establishment U.S. Agent for Malaysia · Medical device establishment U.S. Agent for Pakistan