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Free FDA Registration Services!
We charge only Annual US Agent Fee.

FDA Registration

US FDA Registration in India via I3CGLOBAL can avoid conflicts when you are working with multiple distributors or agents. We assure permanent FDA compliance with regulations time by time, year by year, no matter your commercial relationship with distributors and importers in the USA.

US FDA Registration Process

All facilities involved in the processing of food, drugs, medical devices, cosmetics must complete the US FDA Registration. The requirements are from the U.S.Food and Drug Administration. Failure to register will prevent entering the US market. All foreign facilities must name a US Agent when registering the facilities.

We provide FDA Registration online to below industries

Business owners and their places of activity, so-called establishments or facilities, engaged in any activity which affects the quality of the product such as repacking, re-labeling, storage, or production in any of the FDA regulated industries must REGISTER with the FDA.

Drugs

The following type of establishments can approach us for FDA Registration.

 

  1. Over-the-counter Drug manufacturers and exporters
  2. ANDA/NDA approved drug product manufacturers
  3. Active Pharmaceutical ingredient (API) manufacturers and exporters
  4. Medicated cosmetics manufacturers and exporters
  5. Analytical Test facilities
  6. Biologicals

 

We help manufacturers planning to export Over-the-counter (OTC) drugs. These products are generally safe and classified under ‘Generally Recognized as Safe and Effective’ (GRASE). No additional requirements are other than Establishment Registration, NDC, and Listing.

 

DUNS Number is mandatory to proceed with FDA Drug Establishment Registration.

 

More detailed information about the Drug Establishment Registration.

 

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It is important to know that the FDA Registration for Medical Device(s) can be initiated for:

 

  1. Direct FDA Registration is permitted only for 510k exempted devices.
  2. 510k non-exempted devices can be registered only after FDA 510k

 

Medical Device Name, Device FDA Code, FDA regulation Number, Class of the device, Intended use, the propitiatory name is required for completing the registration process.

 

More detailed information about the FDA Medical Device Registration & Listing.

 

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Food (Human & Animals)

Attention – Manufacturers, Exporters, Distributors & Importers of food items to the USA.

 

The following type of products only can be registered.

 

  1. Human & Animal food for consumption
  2. Food Supplements or Nutraceuticals
  3. Food Ingredients
  4. Acidified & Canned foods
  5. Organic Certified Food products

 

More Information about Food Facility FDA Registration.

 

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FDA Registration for Cosmetics

 

FDA Registration for Cosmetics can be processed only if the cosmetics are already available in the USA.

 

FDA Registration is Voluntary. The regulation is called Voluntary Cosmetic Registration Programme. VCRP can be applied by the manufacturer of the cosmetic product and the brand owner.

 

More detailed Information about VCRP.

 

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Frequently Asked Questions

How do I get a US FDA license?

US FDA will not provide a license for sale. FDA registration and Listing allow manufactures to sell their products in the US market. US FDA License is a common word used by the public without knowing the actual procedure.

What is the FDA registration number?

FDA Registration number provided +by FDA soon after the confirmation of registration. This is applicable to Food, drugs, cosmetics, and medical devices.

What is the difference between FDA and FDA registered?

FDA approves only prescription drugs, research formulas, critical medical devices only. There is no FDA approved drug database for the public.

How do you find if a product is FDA approved?

FDA approves only prescription drugs, research formulas, critical medical devices only. There is no FDA approved drug database for the public.

How much is FDA approval?

The cost and timeline for FDA approval depend on the product and nature of the product.

Does Tea need FDA approval?

Tea falls under the food category. No approval required. Register the facility and comply with labeling requirements and start marketing in America.

How do I verify FDA certification?

FDA will not issue FDA certificate.

How do I find my FDA number?

FDA number and registration details cane be verified

Medical Device: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm

Drug Establishments: https://www.accessdata.fda.gov/scripts/cder/drls/default.cfm

Drug Labels: https://dailymed.nlm.nih.gov/dailymed/

How long FDA approval takes?

FDA approval depends on the product and nature of the product and its intended use.

Does my product need FDA approval?

If the medical device falls under high risk, 510k approval is required or any generic /prescription drugs need approval or certain food /pharma color additives to need approval.

How to verify my facility needs FDA approval or FDA registration?

n case of Medical Devices based on the classification and device FDA code or in the case of Drugs if not covered in monograph you can understand prior approval is required or not!