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