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.
