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FDA Registration Services for Food, Drug, Medical Device and Cosmetics

FDA registration is a mandatory requirement for food, drug, and medical device facilities. Registration for cosmetics is not mandatory.

 

We offer a one-stop solution for FDA registration for food, drug, medical device, and cosmetics.

FDA registration

FDA registration is required to sell products in the USA? 

Yes, for most of the products, FDA facility registration is mandatory before marketing the products in the USA. However, US FDA registration requirements vary based on the product category.

Here is the summary of the FDA registration cost and timeline.

 

Product category Registration  requirement Exemptions FDA Fee Our fee and completion timelines
Food The facility that is involved  in manufacturing/processing, packing, or holding of food for human or animal
consumption in the United States
Farms

Retail store

Home-based facilities

Not applicable $ 299 per year. It will take 2 business days to complete the FDA food facility registration. The fee includes the  US Agent fee
Drug Manufacturers, repackers, labelers, salvagers, testing facilities, API manufacturer, OTC drug manufacturer, the prescription drug manufacturer, the Animal drug manufacturer Bio-equivalence  facility

Clinical testing facility

Importers who do not perform any operation

Private label distributors who do not perform any operation

Not applicable

However,  facilities have to pay the fee based on the product category  OMUFA. GDUFA  or PDUFA

$ 299 per year. It will take 2 business days to complete the FDA drug  registration
Medical Device Manufacturer, packer, foreign exporter, contract manufacturer, re-labeler, repacker, initial importer, specification developer, A distributor who is not also an importer

Manufacturer of components

$ 5546 for FY 2021 Our fee is $ 299. It will take 4 business days to complete the  FDA medical device registration after you pay the FDA.
Cosmetics Not mandatory NA $ 299

 

FDA US Agent is required for foreign facility  FDA registration purposes.  US Agents acts as a point of contact to FDA to communicate with the foreign manufacturer.

What information is required for FDA registration?

You have to complete the online form on our website. There is not additional document or information required for FDA registration.

Difference between FDA registration and FDA approval

FDA approval means the review of the safety, efficacy, or equivalency data of the product.

FDA registration is not the same as FDA approval. FDA approval is not required for food, dietary supplements, most class I medical devices, or OTC drugs. However, you may have to comply with general requirements such as labeling, food safety regulations, or GMP for each product category.

However, FDA approval is required for prescription drugs,  class II and class III medical devices, and food additives.

If you can any questions about FDA registration, contact us. 

 

 

 

 

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