Who Should Register: Any domestic or foreign establishment involved in the manufacture, repackaging, relabeling, importing, or initial distribution of medical devices intended for commercial distribution in the United States.
Governing Authority: FDA Medical Device Establishment Registration is governed by 21 CFR Part 807 (FD&C Act § 510). Quality system under 21 CFR Part 820; labeling under 21 CFR Part 801.
Submission Method: Medical Device Establishment Registration and Device Listing are electronically submitted through the FDA's FURLS/DRLM platform.
Eligibility Requirements: Domestic and foreign establishments must maintain valid business information and obtain a recognized Unique Facility Identifier (UFI). Foreign establishments are also required to appoint a U.S. Agent located within the United States.
Registration Outcome: Upon successful registration, the FDA assigns an FDA Establishment Identifier (FEI) and an Owner/Operator Number, enabling establishments to complete device listings, import documentation, and other FDA regulatory submissions.
Annual Renewal: FDA Medical Device Establishment Registration must be renewed annually every October 1 through December 31 of each fiscal year, including MDUFA user fee payment.
Foreign Establishment Requirement: Foreign establishments are also required to appoint a U.S. Agent located within the United States and must designate a qualified U.S. Agent to serve as the official communication representative between the establishment and the FDA.
Comprehensive Support: Our end-to-end registration services include establishment registration, device listing, regulatory review, submission management, compliance guidance, and U.S. Agent representation for foreign manufacturers.
Device Listing Requirement: Every marketed medical device must be individually listed with the FDA, including applicable product codes, device classifications, and premarket submission references such as 510(k), PMA, or De Novo authorization numbers, where applicable.
Consequences of Non-Compliance: Failure to maintain FDA Medical Device Establishment Registration may result in import refusals, detention without physical examination (DWPE), warning letters, product seizures, injunctions, marketplace restrictions, and other enforcement actions that may significantly impact U.S. market access and business operations.
