FDA US Agent with Registration Support

FDA US Agent providers offering registration and listing support can provide additional value beyond basic agent services. This directory lists providers that offer these specialized services.

FDA US Agent Providers

Compare providers and request quotes

EAS Consulting Group

EAS Consulting Group specializes in FDA regulatory matters, offering expert guidance and compliance solutions for industries regulated by the FDA, USD...

📍 Alexandria, US

AlvaMed (FDA US Agent Representation)

AlvaMed provides comprehensive regulatory consulting for the medical device industry, specializing in FDA US Agent Representation, 510(k) submissions,...

📍 Irvine, US

FDA Solutions Group, LLC

FDA Solutions Group, LLC is a regulatory compliance company specializing in FDA registration and listing services for food, beverages, dietary supplem...

📍 Miami, United States

Willow Glen Consultancy LLC

Willow Glen Consultancy LLC offers FDA registration and U.S. Agent services for international and domestic food facilities and medical device establis...

📍 San Diego, USA

MarketReady Insights

MarketReady Insights offers expert regulatory guidance and consulting services for CPG brands and ingredient suppliers. They make regulatory complianc...

📍 London, UK

FDAAgentPro

FDAAgentPro provides expert U.S. FDA Agent, Registration, Export Certificate, and FSVP Agent services for foreign and domestic companies. Ensure compl...

📍 Miami, US

mdi Consultants

mdi Consultants offers expert FDA regulatory compliance services, specializing in U.S. Agent representation for foreign medical device, pharmaceutical...

📍 New York, US

Liberty Management Group (FDA Registration & US Agent)

Liberty Management Group Ltd is a globally recognized FDA, CE Marking, and ISO consulting firm headquartered in Illinois, USA. They specialize in FDA ...

📍 Aurora, USA

Compliance Insight, Inc.

Regulatory consulting firm specializing in FDA compliance for life sciences: services include U.S. Agent, registration & listing, audits, GMP/GCP, war...

📍 Kitchener, Canada

QA/RA Consulting Group, Inc.

QA/RA Consulting Group, Inc. offers expert regulatory affairs, quality management, and product development services for medical devices, IVDs, and com...

📍 Pittsburgh, US

Food Consultations (FDA Registration & US Agent)

Provides FDA registration and US Agent services for food facilities, including compliance with Bioterrorism Act requirements. Specializes in navigatin...

📍 Seattle, US

FDABasics

FDABasics provides essential resources and guidance for navigating FDA regulations, helping businesses ensure compliance and market access.

📍 Orlando, US

Magneco LLC

Magneco LLC offers comprehensive FDA regulatory consulting and support for food and beverage exporters. They specialize in FDA registration, U.S. Agen...

📍 Houston, US

ITB Holdings LLC

ITB Holdings LLC is a U.S. Agent and FDA compliance service provider, assisting foreign companies with FDA registration, U.S. Agent designation, and n...

📍 Orlando, US

MedEnvoy Global

MedEnvoy Global is a leading regulatory consulting firm specializing in medical device market entry and compliance in the US and globally. They offer ...

📍 Austin, US

Catain Labs

Catain Labs offers comprehensive FDA regulatory consulting, eCTD publishing, and US Agent services for pharmaceutical and biotech companies. They simp...

📍 New Jersey, US

Emergo by UL

Emergo by UL offers comprehensive regulatory consulting and human factors expertise for medical device and IVD companies seeking global market access....

📍 Austin, US

Obelis Group

Obelis Group is your trusted partner for global regulatory compliance, specializing in market access for Medical Devices, Cosmetics, Food Supplements,...

📍 Brussels, BE

Global Regulatory Partners

Global Regulatory Partners (GRP) offers end-to-end regulatory affairs and compliance services for pharmaceuticals, medical devices, cosmetics, nutrace...

📍 Boston, USA

Regulatory Compliance Associates

Regulatory Compliance Associates (RCA) is a leading life science consulting firm specializing in regulatory affairs and compliance for pharmaceutical ...

📍 Wisconsin, US

FDA Regulatory Affairs

RAPS is the leading global authority for professionals dedicated to the regulatory field. They offer resources and support for navigating FDA regulati...

📍 Boston, US

Global Import Agent

Global Import Agent provides expert US regulatory compliance consulting for food, beverages, supplements, and cosmetics. They simplify FDA requirement...

📍 Kirkcaldy, GB

FDA Agent Pro

FDA Agent Pro provides services for FDA-regulated industries, including facility registration, product listing, and export certifications. They facili...

📍 United States, US

Catain Labs

Catain Labs offers comprehensive FDA regulatory consulting, eCTD publishing, and US Agent services for pharmaceutical and biotech companies. They simp...

📍 United States, US

Pineprep

Pineprep offers comprehensive regulatory services for medical device and IVD companies, specializing in FDA US Agent representation, Certificate to Fo...

📍 Arlington, US

Medical Device Regulatory Services

Emergo by UL offers comprehensive regulatory consulting and market access services for medical devices and IVDs globally. They specialize in device re...

📍 St. Louis, US

Regulatory Compliance Associates

Regulatory Compliance Associates (RCA) is a leading life science consulting firm specializing in regulatory affairs and compliance for pharmaceutical ...

📍 Wisconsin, US

FDA Registration Services

FDA Registration Services facilitates submissions to the U.S. Food and Drug Administration, including facility registrations and product listings for ...

📍 United States, US

Medical Device Academy

Medical Device Academy, Inc. is a quality and regulatory consulting firm specializing in FDA 510(k) submissions, quality system implementation, and FD...

📍 US

RQMIS

RQMIS provides expert regulatory, clinical, and quality consulting for medical device companies. They specialize in FDA submissions, US Agent services...

📍 Amesbury, USA

Sotas

Sotas provides expert US FDA Agent services for foreign medical device manufacturers, ensuring smooth market entry and compliance with US regulations....

📍 Haverfordwest, GB

Artixio

Artixio offers scalable regulatory consulting solutions for the entire product lifecycle, powered by AI. They provide global regulatory expertise and ...

📍 US

TechLink International LLC

TechLink International provides essential FDA compliance services, including US Agent representation, Initial Importer services, and Registration & Li...

📍 US

Liberty Management Group

Liberty Management Group is a leading US FDA agent and registration service provider for foreign food, drug, and medical device establishments. They o...

📍 Aurora, USA

Biotech Research Group

Biotech Research Group (BRG) is a full-service regulatory and product development consulting firm specializing in FDA compliance, biologics, medical d...

📍 USA

Asia Actual, LLC

Asia Actual provides expert medical device regulatory and market access consulting for Asian markets. They help manufacturers navigate complex registr...

📍 Austin, US

Provision Consulting Group, Inc.

Provision FDA is a U.S. FDA regulatory consulting firm specializing in helping businesses, especially those outside the U.S., navigate FDA regulations...

📍 Chino Hills, US

GlobalCompliance Solutions

Leading global regulatory compliance consultancy serving medical device manufacturers worldwide with comprehensive regulatory services.

📍 Boston, US

MedReg International

Specialized regulatory consultancy providing end-to-end compliance solutions for medical devices, IVDs, and combination products across all major mark...

📍 London, UK

Regulatory Excellence Partners

Boutique regulatory consultancy offering personalized, high-touch regulatory services for innovative medical device companies and startups.

📍 San Francisco, US

CENIT Consulting (US FDA Agent)

U.S. FDA Agent for Medical Devices & IVD. Fast, predictable service with 1 business day FDA notice forwarding. Specialized in foreign establishments o...

📍 Houston, US

Buyer's Guide

FDA regulations (21 CFR Part 807[1]) require all foreign medical device establishments to designate a U.S. Agent (also called FDA US agent or FDA U.S. agent) when registering with the FDA[1].

This requirement applies to:

  • Foreign medical device manufacturers placing devices on the U.S. market[1] — a FDA US agent is mandatory for registration
  • Foreign specification developers developing device specifications[1] — require U.S. agent FDA services
  • Foreign contract manufacturers manufacturing devices for others[1] — must appoint a FDA agent for foreign manufacturer
  • Foreign repackagers/relabelers repackaging or relabeling devices[1] — need FDA US agent services
  • Foreign initial distributors/importers importing devices into the U.S.[1] — require U.S. agent FDA designation

Note: The U.S. Agent must be physically located in the United States[1] and available during normal business hours[1]. This requirement applies regardless of device class or premarket approval status[1].

Frequently Asked Questions

What does an FDA U.S. Agent do?
An FDA U.S. Agent is a person or entity located in the United States who serves as the official point of contact for the FDA regarding a foreign establishment's medical device registration and listing. The agent acts as a communications intermediary between the foreign manufacturer and the FDA.
Is a U.S. Agent required for all foreign manufacturers?
Yes, FDA regulations require all foreign establishments to designate a U.S. Agent when registering with the FDA. This requirement applies regardless of device class or whether the device requires premarket approval.
What affects FDA U.S. Agent pricing?
U.S. Agent pricing varies based on service scope, portfolio size, response expectations, additional support services, and contract terms. Some providers offer basic agent services for a few hundred dollars per year, while comprehensive packages can cost significantly more.
What should I check before choosing a U.S. Agent?
When selecting an FDA U.S. Agent, evaluate reliability and track record, responsiveness (SLA for forwarding FDA communications), FDA experience, change control and notification terms, technology and communication, additional services, and pricing transparency.
Can I change my FDA U.S. Agent?
Yes, you can change your FDA U.S. Agent at any time by updating your establishment registration in the FDA's FURLS system. The change typically takes effect immediately in the FDA system.
Compare over 70 vetted providers and request quotes instantly
Free • No signup required
Get Quotes Now →