FDA LISTING INC: EXPERIENCED ADVISORS FOR FULL-SERVICE FDA REGISTRATION & COMPLIANCE
+1 212 444 8202
U.S. FDA Registration
& Labeling Compliance Assistance
Medical Devices
Complying with the FDA’s medical device regulations is crucial for device manufacturers and distributors. At FDA Listing Inc., we are dedicated to helping you meet these standards to guarantee your device’s safety, quality, and regulatory compliance in the U.S. market.
Our expert team offers end-to-end support throughout the medical device compliance process, covering everything from facility and facility and device registrations to UDI requirements and labeling compliance. We ensure your products meet FDA requirements for a seamless entry into the market.
Medical Devices
Complying with the FDA’s medical device regulations is crucial for device manufacturers and distributors. At FDA Listing Inc., we are dedicated to helping you meet these standards to guarantee your device’s safety, quality, and regulatory compliance in the U.S. market.
Our expert team offers end-to-end support throughout the medical device compliance process, covering everything from facility and facility and device registrations to UDI requirements and labeling compliance. We ensure your products meet FDA requirements for a seamless entry into the market.
Device Establishment Registration & Device Listing
According to the U.S. FDA, all medical device establishments that develop, manufacture, pack, assemble, label, export, or import medical devices.
FDA GUDID & Unique Device Identifier UDI
The FDA has started the Unique Device Identification (UDI) system to identify and track all medical devices marketed in the United States.
FDA Device
Labeling Requirements
The FDA defines a medical device as any product used to diagnose, treat, cure, or prevent diseases or health conditions.
FDA Registration
Certificate & US Agent
Companies registered with the FDA often seek a certificate to use as proof of registration when dealing with trade or industry partners.
FDA Import Alert
& Detention Assistance
FDA Import Alerts protect US consumers from products produced at facilities with a known history of violations. After identifying a violation.
FDA
Export Certificate
The export certificate is an official document issued by the FDA that provides information on a product or facility’s FDA.
Device Establishment
Registration & Device Listing
According to the U.S. FDA, all medical device establishments that develop, manufacture, pack, assemble, label, export, or import medical devices.
FDA GUDID
& Unique Device Identifier UDI
The FDA has started the Unique Device Identification (UDI) system to identify and track all medical devices marketed in the United States.
FDA Device
Labeling Requirements
The FDA defines a medical device as any product used to diagnose, treat, cure, or prevent diseases or health conditions.
FDA Registration
Certificate & US Agent
Companies registered with the FDA often seek a certificate to use as proof of registration when dealing with trade or industry partners.
FDA Import Alert
& Detention Assistance
FDA Import Alerts protect US consumers from products produced at facilities with a known history of violations. After identifying a violation.
FDA
Export Certificate
The export certificate is an official document issued by the FDA that provides information on a product or facility’s FDA.
Frequently Asked Questions (FAQ)
Who must register a medical device facility and list devices with the FDA?
Any domestic or foreign company that manufactures, processes, package-labels, contract-manufactures, or imports medical devices for U.S. commercial distribution must complete annual establishment registration and list every active device.
What is the difference between device establishment registration and device listing?
Establishment Registration: Identifies the physical manufacturing, contract processing, or importing facility in the FDA database.
Device Listing: Identifies the specific medical device formulations, brand names, product codes, and premarket submission numbers tied to that registered facility.
What are the submission requirements for the FDA GUDID database and UDI implementation?
Labelers must assign a Unique Device Identifier (UDI) consisting of a Device Identifier (DI) and Production Identifier (PI) to device labels. The primary DI attribute data must then be submitted electronically to the Global Unique Device Identification Database (GUDID).
What elements are required on a compliant U.S. medical device label?
Device labeling must feature the device name, manufacturer or distributor contact information, intended use, directions for use, safety warnings, lot or serial numbers, and a human-readable and machine-readable UDI carrier code.
Do foreign medical device establishments require a U.S. Agent?
Yes, foreign medical device manufacturers, processors, and exporters must designate a U.S. Agent located physically in the United States to act as the primary liaison for official FDA communications, emergency inquiries, and inspection arrangements.
How do you resolve an FDA import detention for a medical device shipment?
If a medical device shipment is detained at the U.S. border due to unlisted product codes, missing 510(k) clearances, or non-compliant labeling, the importer must present formal evidence, regulatory documentation, or corrected listing records to the FDA Division of Import Operations within the required window to secure release.