Your Complete Guide to U.S. FDA Compliance for Food, Drug, Cosmetic & Medical Device Companies

Welcome to the FDA Educational Information Center by FDA Registration Assistance — your central hub for understanding how to legally manufacture, export, import, and sell FDA-regulated products in the United States.

This page is designed for global manufacturers, U.S. importers, Amazon sellers, and private label brands that need clear, organized guidance across every major FDA product category. Here you’ll find step-by-step educational content, cost explanations, registration requirements, and compliance resources — all in one place.

We proudly support 700+ companies in 75+ countries, helping them complete registrations quickly, remain compliant, and avoid costly delays at U.S. customs.

FDA Regulated Product Categories

Food Facilities & Dietary Supplement Companies

Any facility that manufactures, processes, packs, or holds food for U.S. consumption must complete FDA Food Facility Registration. If you import food into the United States, you must also comply with the Foreign Supplier Verification Program (FSVP), which typically requires a qualified FSVP Agent.

This category often includes conventional foods, beverages, seafood, dairy, snacks, pet food, and many dietary supplement operations (depending on the business activity and facility role).

Core Food Compliance Pages

Foreign Food Facility Registration

Domestic Food Facility Registration

Food Ingredients & Label Review

Food DUNS Request Assistance

Import Alert Removal

Food U.S Agent Services

Foreign Supplier Verification Program (FSVP) for Amazon Sellers

Foreign Supplier Verification Program (FSVP)

Prior Notice

HACCP Plan Review

Food Canning Establishment (FCE-SID)

Food Safety Plan

Consulting & Shipment Monitoring Services

FDA Acidic Food / Low Acid Food Intake Form

More Food Compliance Resources

FDA Registration Checklist

FSVP Agent Cost

Renew Your FDA Food Facility Registration

FDA Compliance for Amazon Food Sellers

FSMA Compliance and Food Safety Systems for FDA-Regulated Facilities

U.S Agent for Food Companies

How to Appoint a U.S. Agent for FDA Food Registration

FDA Registration for Beverage Manufacturers

FDA Registration for Low-Acid Canned Foods (LACF)

FDA Registration for Pet Food Manufacturers

FDA Registration for Seafood Importers

FDA Food Facility Registration Cost

FDA Food Labeling Requirements for Imported Food

FDA Food Facility Registration Renewal 2026

Fast FDA Food Facility Registration

FDA Compliance Consulting for Food Importers

FDA Registration for Food Warehouses

Replace My Current FSVP Provider

FDA Food Facility Registration Fee Cost 2026

Trusted Food FDA US Agent

HACCP Meaning: What Is HACCP in Food Safety?

FDA Rules for Importing Fish and Seafood

SIMP Compliance for Seafood Importers

How to Get FDA Approval for Food

FDA Food Label Regulations

U.S. FDA Food Certificate: What It Is and When It’s Required

Leading Firm for FDA Food Facility Registration

Common Mistakes When Doing FDA Food Facility Registration

Do Non-Alcoholic Beverages Need TTB Approval?

TTB Registration

FDA Requirements for Alcohol-Free Beer in the U.S.

What Documents Are Needed for FDA Food Facility Registration?

Alcohol Beverage Compliance Consultant USA

Third-Party FDA Food Facility Registration Verification Letter

How to Import Beer, Wine, and Spirits into the U.S.

COLA Label Approval Assistance for Alcohol

TTB Importer Permit Help (Step-by-Step Service)

Do Alcohol Brands Need FDA Registration?

TTB Registration Cost

FCE/SID Intake Form

Importing Human Foods into the U.S. (FDA Compliance Guide)

Importing Food Products into the United States

Guidance for Industry: Registration of Food Facilities

FDA & Dietary Supplements

What Is the FDA Food Labeling Guide and Why It Matters

Guidance for Industry: Foreign Supplier Verification Programs for Importers

Frequently Asked Questions on FSMA

FDA Registration for Food Importers – U.S. Agent Required

FDA Registration for Baby Food

FDA Registration for Pet Food & Treats

FDA Registration for Chocolate Products

FDA Registration for Candy & Confectionery

FDA Registration for Energy Drinks

FDA Registration for Bottled Water

FDA Registration for Soft Drinks & Sodas

FDA Registration for Juice Products

FDA Registration for Hot Sauce & Salsas

FDA Registration for Cooking Oils

FDA Registration for Sauces & Condiments

FDA Registration for Food Ingredients

FDA Registration for Nuts & Seeds

FDA Registration for Spices & Seasonings

FDA Registration for Bakery Products

FDA Registration for Snack Foods

FDA Registration for Rice

FDA Registration for Pulses

FDA Registration for Flour & Grain Products

FDA Registration for Ice Cream

FDA Registration for Frozen Dairy

FDA Registration for Milk & Cream Products

FDA Registration for Cheese

FDA Registration for Dairy Products

FDA Registration for Jerky & Dried Meats

FDA Registration for Poultry Products

FDA Registration for Meat Products

FDA Registration for Fish & Tuna Products

FDA Registration for Shelf-Stable Foods

FDA Registration for Frozen Foods

FDA Registration for Ready-to-Eat Foods

FDA Registration for Processed Foods

FDA Registration for Packaged Foods

FDA Registration for Organic Food Products

FDA Registration for Fresh Produce

FDA Registration for Cut & Packaged Fruit

FDA Registration for Salad & Ready Meals

FDA Registration for Vegan Food Products

FDA Registration for Plant-Based Foods

FDA Registration for Gluten-Free Products

FDA Registration for Keto Food Products

FDA Registration for Halal Food Products

FDA Registration for Kosher Food Products

FDA Registration for Frozen Meals

FDA Registration for Ready Meals & Meal Kits

FDA Registration for Canned Foods

FDA Registration for Instant Foods

FDA Registration for Food Kits & Subscription Meals

FDA Registration for Takeout & Prepared Foods

FDA Registration for Microwaveable Foods

FDA Registration for Vacuum-Sealed Foods

FDA Registration for Shrimp Importers

FDA Registration for Salmon Products

FDA Registration for Crab & Lobster Products

FDA Registration for Shellfish Products

FDA Registration for Smoked Fish Products

FDA Registration for Dried Seafood Products

FDA Registration for Canned Tuna & Fish

FDA Registration for Honey Products

FDA Registration for Maple Syrup

FDA Registration for Jam & Jelly Products

FDA Registration for Nut Butters

FDA Registration for Chocolate Spreads

FDA Registration for Syrups & Sweeteners

FDA Registration for Sugar Products 

FDA Registration for Functional Beverages

FDA Registration for Herbal Drinks

FDA Registration for Tea Products

FDA Registration for Coffee Products

FDA Registration for Protein Drinks

FDA Registration for Sports Drinks

FDA Registration for Smoothies & Blended Drinks

FDA Registration for Coconut Water

FDA Registration for Salt Products 

FDA Registration for Vinegar Products

FDA Registration for Pickled Foods

FDA Registration for Catering Food Production Facilities

FDA Registration for Commissary Kitchen Facilities

FDA Registration for Food Processing Plants 

FDA Registration for Food Warehousing Facilities

FDA Registration for Food Distribution Companies

FDA Registration for Ingredient Blending Facilities

FDA Registration for Contract Food Manufacturers

FDA Registration for School Food Suppliers

FDA Registration for Hospital Food Products

FDA Registration for Airline Catering Food

FDA Registration for Military Food Suppliers

FDA Registration for Large-Scale Meal Providers

FDA Registration for Stick Pack Food Products

FDA Registration for Sachet Food Products

FDA Registration for Single-Serve Food Packaging

FDA Registration for Portion-Controlled Food Products

FDA Registration for Food Pouch Packaging

FDA Registration for Flexible Packaging Food Products

FDA Registration for Resealable Packaged Foods

FDA Registration for Multi-Pack Food Products

FDA Registration for Food Packaging Facilities

FDA Registration for Bulk Food Suppliers 

FDA Registration for Foodservice Supply Companies

FDA Registration for Fermented Foods

FDA Registration for Pasta & Noodles

FDA Registration for Breakfast Cereals

FDA Registration for Oats & Granola Products

FDA Registration for Cooking Sauces

FDA Registration for Baby Snacks & Toddler Foods

FDA Registration for Ethnic Food Products

FDA Registration for Specialty International Foods

FDA Registration for Bulk Food Ingredients

FDA Registration for Private Label Food Brands

FDA Registration for Co-Packed Food Products

Is My Food Label FDA Compliant?

Why FDA Rejects Food Labels?

Fix Your Food Label Before Importing to the U.S.

FDA Food Nutrition Facts Label Requirements

Ingredient List Requirements for Food Labels

Allergen Labeling Requirements

Net Quantity Statement Requirements for Food Labels

Country of Origin Labeling for Imported Food

Exporting Food to the U.S.? Labeling Guide + Review

How to Make Your Food Label U.S. FDA Compliant

FDA Food Label Review for Amazon Sellers

How to Avoid Amazon Food Listing Removal

FDA Label Requirements for Selling Food on Amazon FBA

Food Label Compliance for Retail & E-Commerce

U.S. FDA Process Filing for Overseas Food Facilities

U.S. Food Import Regulations (FDA Compliance Guide)

How to Export Low-Acid Foods to the U.S.

FDA Requirements for Canned Food Imports

LACF Compliance for International Food Exporters

FDA Process Filing Guide for Foreign Manufacturers

Importing Acidified Foods to the U.S.

FDA Food Canning Rules for Global Suppliers

What is FCE Registration? FDA Guide for Food Canning

What is an SID Number? FDA Process Filing Explained

What Foods Require FCE & SID Filing?

FCE vs SID: What’s the Difference?

Acidified vs Low-Acid Foods | FDA Requirements Explained

FDA Process Filing Requirements for Shelf-Stable Foods

What is a Food Canning Establishment (FCE)?

Importing Canned Foods to the U.S.? FCE & SID Explained

How to Export Canned Food to the U.S.

FDA Requirements for Importing Low-Acid Canned Foods

FCE -SID Filing for Foreign Food Manufacturers

U.S. FDA Process Filing for Overseas Food Facilities

Exporting Acidified Foods to the U.S. | Full FDA Guide

FDA Rules for Importing Shelf-Stable Foods into the U.S.

Do Foreign Food Facilities Need FCE Registration?

How to Register a Food Canning Facility with the FDA

Importing Canned Foods to the U.S.? FCE & SID Explained

FDA Compliance for International Food Exporters

FDA Requirements Before Shipping Canned Food to the U.S.

What You Need Before Your First Canned Food Shipment to the U.S.

FCE & SID Checklist Before Exporting to the U.S.

Why Your Canned Food Shipment Was Held by FDA

How to Avoid FDA Detention for Canned Food Imports

Documents Required for Importing Low-Acid Foods into the U.S.

FDA Compliance Checklist for First-Time Food Exporters

What Happens If You Ship Without FCE & SID Filing?

How to Prepare Your Canned Food Shipment for U.S. Customs

Do I Need FCE Registration to Export Food to the U.S.?

Can I Export Canned Food Without FCE Registration?

How Long Does FCE Registration Take?

Do Acidified Foods Require FDA Process Filing?

What Happens If My FCE Registration Is Incorrect?

Is FCE Registration Required for All Canned Foods?

How to Export Hot Sauce to the U.S.

Exporting Shelf-Stable Sauces to the U.S. 

FDA Registration for Exporting Canned Vegetables to the U.S.

FDA Rules for Exporting Acidified Beverages to the U.S.

First-Time Exporting Canned Food to the U.S.?

Beginner Guide to FDA Food Canning Registration

How to Enter the U.S. Food Market?

FDA Compliance Guide for New Food Exporters

What You Need to Sell Shelf-Stable Food in the U.S.

Step-by-Step FDA Registration for Food Manufacturers Abroad

FDA Process Filing Made Simple for Exporters

U.S. Market Entry Guide for Canned Food Manufacturers

Everything You Need Before Exporting Food to the U.S.

Is Your Supplement Label FDA Compliant? Find Out Before You Sell

One Label Mistake Can Get Your Supplement Detained by FDA

Before You Sell Supplements on Amazon, Read This First

FDA Supplement Label Review That Could Save You Thousands

Stop FDA Label Problems Before Your Products Reach the U.S.

Most Supplement Labels Fail FDA Requirements — Does Yours?

Avoid Costly Supplement Label Reprints With FDA Review Experts

Your Supplement Label May Be Non-Compliant Without You Knowing

FDA Label Review for Supplements — Fast, Professional & Trusted

Don’t Risk an FDA Warning Letter Over Your Supplement Label

Selling Supplements in the U.S.? Your Label Matters More Than You Think

FDA Experts Review Your Supplement Labels Before It’s Too Late

Why Amazon Supplement Sellers Are Getting Their Labels Reviewed First

The FDA Is Cracking Down on Supplement Labels — Be Prepared

Get Your Supplement Labels Reviewed Before Customs Flags Your Shipment

Drug Establishments & Pharmaceutical Companies

Drug manufacturers, relabelers, repackers, and private label distributors may be required to complete FDA Drug Establishment Registration and maintain appropriate drug listings. Depending on your role, you may also need an NDC Labeler Code, proper product listing, and annual updates.

This category commonly includes OTC drug companies, contract manufacturers, private label distributors, and certain pharmaceutical supply chain entities.

Core Drug Compliance Pages

Drug Establishment Registration

Labeler Code Registration

OTC Drug Listing

FDA Drug Listing Certificate

Drug DUNS Assistance

Drug Labeling & Ingredient Review

Drug U.S Agent Services

Drug Master Files (DMF)

More Drug Compliance Resources

Who Must Register a Drug Facility with the FDA?

Drug Import Documentation Checklist

Electronic Drug Registration and Listing (eDRLS) Support

Annual Drug Establishment Renewal FDA

#1 Rated Drug Establishment Registrar

FDA Drug Labeling Services

Trusted Drug / Pharmaceutical U.S. Agent

FDA Drug Registration Renewal Help

Sunscreen FDA Registration: Requirements for Selling Sunscreen in the United States

How to Register an OTC Drug with the FDA (Complete Guide)

Is My Product a Cosmetic or an OTC Drug? (FDA Guide)

Does Hand Sanitizer Require FDA Registration?

Is Toothpaste an OTC Drug? FDA Compliance Guide

Do Skincare Products Need FDA Drug Registration?

FDA Drug Listing Rejected? What to Do Next

Transfer Your OTC Drug Registration to a New Agent

FDA Compliance for Overseas OTC Drug Brands

FDA Hand Sanitizer Registration & Listing

FDA Acne Product Registration Requirements

FDA Registration for Pain Relief Products

FDA Antifungal Drug Registration Guide

Struggling with OTC Drug Compliance? We Can Help

FDA Rules for Antiperspirants

Hand Sanitizer Import Requirements – FDA Regulations

OTC Drug Fees Update: OMUFA Changes Explained

Is Your OTC Drug Label FDA Compliant?

FDA OTC Drug Label Review Before You Sell in the U.S.

One OTC Label Mistake Can Trigger an FDA Warning Letter

FDA OTC Label Review Services for Global Manufacturers

Avoid FDA OTC Drug Label Violations Before Launch

Don’t Print Your OTC Labels Before FDA Review

FDA Experts Review Your OTC Drug Labels Fast

Selling OTC Drugs in the U.S.? Review Your Labels First

FDA OTC Drug Label Compliance Made Simple

Your OTC Drug Label Could Be Non-Compliant Without You Knowing

FDA OTC Label Reviews for Creams, Sprays, Serums & Oils

Avoid Costly OTC Drug Label Reprints With FDA Experts

FDA Drug Facts Panel Review Services

FDA OTC Label Review for Amazon & Retail Products

Get Your OTC Drug Labels FDA-Ready Before Importing

FDA Compliance Reviews for OTC Drug Packaging & Claims

Prevent Customs Holds With an FDA OTC Label Review

FDA OTC Drug Label Reviews Trusted by Global Brands

Fast FDA OTC Label Reviews in 24–48 Hours

FDA Review for OTC Drug Claims, Warnings & Directions

Cosmetic Facilities & MoCRA Compliance

The Modernization of Cosmetics Regulation Act (MoCRA) introduced new FDA compliance requirements for cosmetic companies selling into the U.S. market. Depending on your business, you may need cosmetic facility registration, product listing, and a designated Responsible Person.

This category includes skincare, haircare, personal care brands, private label cosmetic sellers, and many e-commerce cosmetic businesses.

Core Cosmetic Compliance Pages

MoCRA Cosmetic Facility Registration

Cosmetic Product Listing

Cosmetic DUNS Request Assistance

Cosmetic Labeling and Ingredient Review

MoCRA Listing Certificate

California Safe Cosmetics Act Reporting (CSCAR)

More Cosmetic Compliance Resources

Who Must Register a Cosmetic Facility with the FDA?

FDA Cosmetic Labeling Requirements – Complete Guide

#1 Rated FDA Cosmetics Registrar

MoCRA Cosmetic Facility Registration Fee

Cosmetic Regulatory Services

Trusted MoCRA/Cosmetics FDA U.S Agent

Are Hair Products Regulated by the FDA?

Do Beauty Brands Need FDA Approval?

What Products Fall Under MoCRA?

Export Cosmetics to the U.S. (MoCRA Compliance Guide)

FDA Registration for Hair Products (MoCRA)

Cosmetic Product Listing for Makeup Products

Are Natural Cosmetics Regulated by the FDA?

Common Cosmetic Labeling Mistakes (FDA Compliance Guide)

FDA Cosmetic Registration Not Submitted? Fix It Now

MoCRA Compliance Issues? Get Help Fast

FDA Registration for Skincare Products

FDA Registration for Body Wash Products

FDA Requirements for Bar Soaps

FDA Registration for Feminine Hygiene Products

FDA Compliance for Deodorants

FDA Requirements for Intimate Wash Products

FDA Registration for Baby Skincare Products

FDA Registration for Beard Oils and Grooming Products

FDA Requirements for Whitening Creams

FDA Registration for Lip Balm Products

FDA Compliance for Teeth Whitening Products

FDA Registration for Nail Polish Products

FDA Registration for Nail Treatments

FDA Warning: When Cosmetics Become Drugs

FDA Compliance for Men’s Anti-Aging Products

FDA Requirements for Perfumes and Fragrances

FDA Compliance for Foot Deodorizing Sprays

FDA Registration for CBD Cosmetics

FDA Compliance for Hemp-Based Skincare

Is Fluoride Toothpaste a Cosmetic or Drug?

When Does Skincare Become an FDA Drug?

FDA Registration for Anti-Aging Products

FDA Registration for Acne Products

FDA Rules for “Paraben-Free” Cosmetics

FDA Compliance for “Sulphate-Free” Products

FDA Requirements for “Clinically Proven” Skincare

Is Your Cosmetic Label FDA & MoCRA Compliant?

FDA Cosmetic Label Review Before You Sell in the U.S.

One Cosmetic Label Mistake Could Put Your Brand at Risk

MoCRA Cosmetic Label Review Services for Global Brands

Selling Cosmetics in the U.S.? Review Your Labels First

Avoid FDA Cosmetic Label Violations Before Launch

Don’t Print Your Cosmetic Labels Before Compliance Review

FDA Experts Review Cosmetic Labels Fast

Your Cosmetic Label Could Be Non-Compliant Without You Knowing

MoCRA Cosmetic Label Compliance Made Simple

FDA Cosmetic Label Review for Skincare, Haircare & Beauty Brands

Avoid Costly Cosmetic Label Reprints With FDA Experts

Cosmetic Ingredient & Claims Review for FDA Compliance

FDA Cosmetic Label Review for Amazon & Retail Products

Get Your Cosmetic Labels U.S. Market Ready

FDA Compliance Reviews for Cosmetic Packaging & Claims

Prevent Customs Holds With a Cosmetic Label Review

Cosmetic Label Reviews Trusted by Global Manufacturers

Fast Cosmetic Label Reviews in 24–48 Hours

FDA Review for Cosmetic Claims, Ingredients & Packaging

Medical Device Manufacturers & Specification Developers

Many medical device companies must complete FDA Establishment Registration and Device Listing before marketing devices in the U.S. Depending on classification and device type, additional steps may apply. Foreign device manufacturers typically need a U.S. Agent.

This category often includes manufacturers, contract manufacturers, specification developers, and private label device companies.

Core Medical Device Compliance Pages

Medical Device Establishment Registration

Medical Device Listing

U.S. Agent for Medical Device Companies

Medical Device Labeling & Product Review

Medical Device DUNS Request Assistance

Medical Device Listing Certificates

More Medical Device Compliance Resources

Class I, II, III Medical Device Classification

Why Foreign Medical Device Companies Need a U.S. Agent

How to Determine Medical Device Classification

Medical Device FDA Registration Checklist

#1 Rated FDA Medical Device Registrar

Trusted Medical Device U.S. Agent

FDA Registration for Medical Gloves 

FDA Requirements for Face Masks (Medical vs Non-Medical)

Do Thermometers Require FDA Registration?

FDA Compliance for Blood Pressure Monitors

FDA Registration for Bandages and Wound Care Products

FDA Registration for Walkers and Mobility Aids

FDA Compliance for Wheelchairs

FDA Registration for Specimen Containers

FDA Requirements for Gauze and Dressings

FDA Registration for Canes and Crutches

FDA Requirements for Manual Hospital Beds

FDA Compliance for Medical Tapes and Adhesives

Complete Guide to Class I Medical Devices (510(k) Exempt)

FDA Registration for 510(k)-Exempt Devices – Fast & Compliant

Are Surgical Tools 510(k) Exempt?

FDA Registration for Surgical Scissors and Instruments

U.S. Agent for Class I Medical Device Manufacturers

Export Class I Medical Devices to the USA (FDA Guide)

FDA Requirements for Overseas Device Manufacturers

FDA Registration for Isolation Gowns (Class I Device)

FDA Requirements for Surgical Drapes

Is Your Medical Device Label FDA Compliant?

FDA Medical Device Label Review Before You Go to Market

One Medical Device Label Mistake Can Delay Your FDA Clearance

FDA Medical Device Label Review Services for Global Manufacturers

Avoid FDA Medical Device Label Violations Before Launch

Don’t Print Your Device Labels Before FDA Review

FDA Experts Review Your Medical Device Labels Fast

Selling Medical Devices in the U.S.? Review Your Labels First

FDA Medical Device Label Compliance Made Simple

Your Medical Device Label Could Be Non-Compliant Without You Knowing

FDA Label Review for Class I & Class II Medical Devices

Avoid Costly Medical Device Label Reprints With FDA Experts

FDA UDI & Medical Device Label Review Services

FDA Medical Device Label Review for Importers & Manufacturers

Get Your Medical Device Labels FDA-Ready Before Importing

FDA Compliance Reviews for Medical Device Packaging & Claims

Prevent Customs Holds With an FDA Medical Device Label Review

FDA Medical Device Label Reviews Trusted by Global Brands

Fast FDA Medical Device Label Reviews in 24–48 Hours

FDA Review for Medical Device Instructions, Claims & Packaging

Import Compliance & U.S. Market Entry

For foreign manufacturers and exporters, FDA compliance is directly tied to U.S. customs clearance. Many issues happen at the port because of missing registrations, incorrect importer details, missing Prior Notice (food), labeling problems, or facility compliance gaps.

This section helps importers and exporters understand how to reduce risk and prevent delays, detentions, and refusals.

Core Import Compliance Pages

FDA Prior Notice Explained

Importer of Record Explained

Import Refusal Prevention

FDA Detention Assistance

How to Remove an Import Alert

More Import & Customs Compliance Resources

What is FDA FURLS?

FDA Registration Company

FDA Requirements for Selling Food on Amazon USA

Importing Food for E-Commerce USA

How to Release FDA Held Shipment

#1 Rated U.S. Agent for FDA Registrations

#1 Rated FDA Food Facility Registrar Company

#1 Rated FDA FSVP Agent

Same-Day U.S. Agent for FDA

Hire an FSVP Agent

FDA Detained My Shipment – Help

FDA Refusal Due to No FSVP – Fix Now

Amazon Food Listing Suspended for FDA Compliance

Amazon Asking for FDA Registration – What to Do

Transfer FDA Registration to a New U.S. Agent

FDA U.S. Agent vs Importer Explained

FDA Registration Assistance

FDA Registration Agent

FDA Registration Consultants

FDA Label Review Help

Importer of Record Service for FDA-Regulated Products

FDA Import Alert Help

U.S. Agent for FDA Registration

What Is the FDA?

FDA Detention Without Physical Examination (DWPE) Explained

Trusted FDA U.S Agent

Complete FDA Compliance for Exporters to the US

FDA Registration and U.S. Agent Services – One Complete Compliance Solution

Best FDA Registration Service for Companies Replacing Their Current Agent

Looking for an Alternative to Your Current FDA Registration Provider?

FDA Registration Verification Help

FDA Registration Support for Importers

FDA Registration Consultant

Is Coconut an Allergen According to the FDA?

What Is a Major Food Allergen According to the FDA?

FDA Establishment Registration

Reliable U.S. FDA Agent Services

Which U.S. Agent Do I Need for FDA Registration?

FDA U.S. Agents vs. FDA Consultants

Alternatives to Big-Name FDA U.S. Agent Firms

Amazon Asking for FDA Registration – What to Do

FDA & Amazon Compliance Guide (Sell Without Risk)

Official FDA U.S. Agents – Trusted, Fast & Fully Compliant

FSVP Gaps Analysis & Compliance

Need a Solution That Handles FDA Registration & U.S. Agent Services?

FDA Registration Assistance Press Releases

Press Releases

Why Companies Worldwide Trust FDA Registration Assistance

FDA compliance is not just a form submission — it is an ongoing process that impacts your ability to sell, ship, and scale in the United States.

Our team supports companies with:

Fast electronic filings, U.S. Agent and FSVP Agent services, renewal management, compliance guidance, and long-term regulatory support — all delivered with clear communication and reliable turnaround times.

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If you’re ready to move forward, start with the category that matches your product type above, or begin with your main entry page:

Register Now – Start Your FDA Process

Frequently Asked Questions About FDA Registration & U.S. Compliance

1. What products require FDA registration to be sold in the United States?

FDA registration is required for companies involved in the manufacturing, processing, packing, labeling, or holding of regulated products such as food, dietary supplements, drugs, cosmetics (under MoCRA), and medical devices. The exact requirement depends on the role of the facility in the supply chain and the product classification. Foreign facilities that export these products to the U.S. must also appoint a U.S. Agent as part of the registration process.

2. Who must register a food facility with the FDA?

Any domestic or foreign facility that manufactures, processes, packs, or holds food for human or animal consumption in the United States must complete FDA Food Facility Registration. This requirement applies even if the company does not sell directly to consumers and only exports through distributors or importers.

3. What is an FSVP Agent and when is it required?

An FSVP Agent is a U.S.-based entity responsible for verifying that imported food meets U.S. food safety standards. This is required when a U.S. importer brings food into the country from a foreign supplier. The FSVP Agent evaluates supplier compliance, hazard controls, and regulatory documentation to ensure the product is safe for U.S. distribution.

4. Do dietary supplement companies need FDA registration?

Yes. If a facility manufactures, processes, packs, or holds dietary supplements for U.S. consumption, it must register as a food facility with the FDA. In addition, dietary supplement labels must comply with FDA labeling regulations and the facility must follow applicable current Good Manufacturing Practices (cGMPs).

5. What is FDA Drug Establishment Registration?

Drug Establishment Registration is required for companies that manufacture, repack, relabel, or distribute drug products in the United States. Registered establishments must also list their commercial drug products with the FDA and maintain annual updates to keep their records active.

6. What is an NDC number and who needs it?

The National Drug Code (NDC) is a unique identifier assigned to drug products listed with the FDA. Companies that manufacture or distribute OTC or prescription drugs in the U.S. must obtain an NDC Labeler Code and submit product listings in order to legally market their products.

7. What are the FDA requirements for cosmetic companies under MoCRA?

Cosmetic companies must now complete FDA cosmetic facility registration, submit cosmetic product listings, designate a Responsible Person, and maintain records for adverse event reporting. These requirements apply to both U.S. and foreign cosmetic manufacturers selling products in the United States.

8. Do medical device companies need FDA registration?

Yes. Medical device manufacturers, contract manufacturers, specification developers, and certain distributors must complete FDA Establishment Registration and list their devices before marketing them in the U.S. Foreign manufacturers are also required to appoint a U.S. Agent.

9. What is a U.S. Agent and why is it required?

A U.S. Agent acts as the official FDA point of contact for foreign facilities. The FDA uses the U.S. Agent to communicate about inspections, compliance issues, shipment questions, and regulatory updates. Without a valid U.S. Agent, a foreign facility cannot maintain an active FDA registration.

10. How often does FDA registration need to be renewed?

Renewal requirements depend on the product category. Food facility registrations must be renewed periodically, while drug and medical device establishments must complete annual updates. Cosmetic facility registrations must also be maintained in accordance with MoCRA requirements. Keeping registrations active is essential to avoid import delays.

11. What happens if my FDA registration is not active?

If your registration is inactive or incorrect, your shipments may be held at the port of entry, delayed, or refused by the FDA. This can lead to storage fees, product loss, and disruption of your U.S. distribution. Maintaining an accurate and active registration is critical for smooth import operations.

12. Is FDA approval required before selling products in the United States?

Not all FDA-regulated products require premarket approval. Many products, such as conventional foods and most cosmetics, do not require FDA approval but must still comply with registration, labeling, and safety requirements. Certain medical devices and drugs do require premarket clearance or approval depending on their classification.

13. Can I sell on Amazon without FDA compliance?

No. Amazon and other e-commerce platforms require sellers to meet all applicable FDA regulations. Failure to comply can result in listing removal, shipment refusal, or account suspension. Proper registration and compliant labeling are essential for long-term success in online marketplaces.

14. How long does the FDA registration process take?

The timeline depends on the product category and how quickly the required information is provided. Most electronic registrations can be completed within a few business days once all documentation is received and verified.

15. How do I start the FDA registration process?

The best way to begin is by identifying your product category and determining the type of registration required. From there, you can submit your facility details, designate a U.S. Agent if needed, and complete the electronic filing process with the FDA.

Our team guides clients step by step to ensure the process is fast, accurate, and fully compliant.

Need More Information?

If you would like us to cover a specific FDA topic that is not yet listed in this Educational Center, or if you need help determining your exact regulatory requirements, we invite you to contact our team.

We are continuously expanding this page to provide the most complete and up-to-date FDA compliance guidance for companies around the world.

📩 Contact FDA Registration Assistance to request additional educational resources or personalized support.