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 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.

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.