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)
Facilities involved in manufacturing, packaging, labeling, or distributing medical devices in the U.S. must register with the FDA.
Manufacturers, initial distributors, contract sterilizers, and repackagers handling medical devices for the U.S. market.
Registration must be completed annually between October 1 and December 31.
Facility details, contact information, device listing, and payment of the annual user fee.
Labels must include the device name, intended use, manufacturer information, and adequate directions for use.
Frequently Asked Questions (FAQ)
Facilities involved in manufacturing, packaging, labeling, or distributing medical devices in the U.S. must register with the FDA.
Manufacturers, initial distributors, contract sterilizers, and repackagers handling medical devices for the U.S. market.
Registration must be completed annually between October 1 and December 31.
Facility details, contact information, device listing, and payment of the annual user fee.
Labels must include the device name, intended use, manufacturer information, and adequate directions for use.