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FDA Responsibilities
What the FDA Regulates
The FDA oversees a broad range of consumer products to protect public health.
Product Safety and Stewardship
The FDA sets and enforces safety standards for food, drugs, medical devices, and cosmetics before and after they reach the market.
Consumer and Product Safety
Through inspections, adverse event monitoring, and recalls, the FDA works to protect consumers from unsafe or mislabeled products.
Product Innovation
The FDA evaluates new ingredients, devices, and formulations, balancing innovation with the evidence needed to ensure safety.
Who Needs to Register
Who Needs to Register With the FDA?
Ensure compliance and thrive in the US market by registering with the FDA. If your business manufactures, processes, or distributes food, cosmetics, medical devices, or drugs, staying current with FDA regulations is essential. GOL helps you navigate the regulatory landscape seamlessly.
99%
Successful registration rate
98%
Clients achieve full compliance
How It Works
Register With the FDA in 4 Simple Steps
A clear, guided path from document prep to full compliance.
01
Document Preparation
Assemble crucial documents, including your business registration certificate and quality management standards, if applicable, to ensure a smooth registration process.
02
US Representative Appointment
Select a US Representative within the country, available during US business hours, to represent your foreign business and facilitate communication with the FDA.
03
FDA Registration Initiation
Kickstart the registration process with the FDA. Processing times vary based on product category, ranging from 10 to 90 days, supported and expedited by GOL.
04
Completion and Compliance
Upon successful FDA registration, GOL seamlessly transfers all pertinent documents to your business, so you have full records of your compliance status.
Our Services
Choose Your FDA Registration Service
Select the service relevant to your product category, and we’ll guide you through the exact requirements.
FDA Food Registration
Position your food and beverage business for compliance excellence. Mandated by the Bioterrorism Act of 2002 and the Food Safety Modernization Act (FSMA) of 2011, registering and updating your facility is essential for exporting to the US.
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FDA Medical Device Registration
Empower your medical device business with streamlined FDA registration. Registration is mandatory for all manufacturers and distributors, whether foreign or domestic.
Learn More →
FDA Cosmetics Registration
Unlock compliance for your cosmetic business under the Modernization of Cosmetics Regulation Act (MoCRA). We navigate the legal framework governing cosmetics in the United States on your behalf.
Learn More →
FAQ
Frequently Asked Questions
Common questions about FDA registration, answered.
Who needs to register with the FDA?
Any business that manufactures, processes, packs, or distributes food, cosmetics, medical devices, or drugs for the US market generally needs to register with the FDA, whether the business is based in the US or overseas.
Do foreign businesses need a US Agent to register with the FDA?
Yes. Foreign facilities registering with the FDA must designate a US Agent who is available during US business hours to communicate with the FDA on the facility's behalf. GOL can serve as your US Agent.
How long does FDA registration take?
Processing times vary by product category, generally ranging from 10 to 90 days. GOL helps prepare accurate documentation upfront to avoid delays and resubmissions.
What happens if I don’t register with the FDA?
Operating without required FDA registration can result in shipments being refused entry at US ports, penalties, and being blocked from selling in the US market.
Does GOL handle food, medical device, and cosmetics registration?
Yes. GOL provides dedicated registration services for FDA Food, FDA Medical Devices, and FDA Cosmetics, each with category-specific requirements and support.
Why Choose GOL
Why Brands Choose GOL for FDA Registration
Specialized FDA expertise
We focus exclusively on FDA registration for food, medical devices, and cosmetics, tracking regulatory changes across all three categories so you don’t have to.
End-to-end solution
From document preparation through US Agent representation to ongoing compliance, one team handles your entire FDA registration, not separate vendors for each step.
23+ years of experience
We’ve helped thousands of businesses across food, supplements, drugs, medical devices, and cosmetics achieve and maintain FDA compliance.
Ready to Register With the FDA?
Talk to our team about the right registration path for your product category.
Services over 5000+ companies with trade compliance and supply chain management solutions.
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