FDA Registration Number and other FDA Requirements

Manufacturers and distributors who plan to market their products in the USA often recognize that the FDA registration number is mandatory. Still, most of them are not aware of other FDA requirements like GMP, listing, label compliance, UDI, prior notice, etc.

There are specific requirements for each product category; if you do not comply, the FDA may detain the product or consider it misbranded. FDA Registration is not a mandatory requirement for cosmetic products. FDA registration is mandatory for drugs and medical devices, but registration number (FEI) is not compulsory.

New FDA Renewal Requirement

The below table provides you with a brief description of FDA requirements for each product category.

FDA Registration and other Requirements

Product	Type of FDA Registration	Other FDA Requirements	More Information
Food	FDA Food Facility Registration. FCE Registration - for acidified / low acid products.	Label Compliance US FDA Agent -for Foreign Facility GMP Compliance Prior Notice	US FDA Food requirements Food Registration Form Food registration certificate Food GMP
Dietary Supplement	FDA Food Facility Registration.	Label Compliance US FDA Agent -for Foreign Facility GMP Compliance Prior Notice	Dietary Supplements Regulations Dietary Supplement GMP Dietary Supplement Registration Form
Medical Device	FDA Medical Device Establishment Registration.	Label Compliance US FDA Agent -for Foreign Establishment GMP Compliance Device Listing Identify Importer / Manufacturer 510k or PMA - if not exempted UDI Compliance	Medical Devices Regulations Medical Device GMP Medical Device certificate Medical Device Registration Form
OTC Drug	FDA Drug Establishment Registration.	Label Compliance US FDA Agent -for Foreign Establishment GMP Compliance NDC Labeler code Drug Listing Identify Importer / Manufacturer Comply with OTC Monograph or NDA / ANDA	Drug Regulations Drug GMP Drug Registration and NDC Labeler code Form Drug registration certificate Drug Listing Form
Cosmetics	Registration is not mandatory, but you can register voluntarily.	Label Compliance Ingredient compliance GMP Compliance	Cosmetic Regulations Cosmetic registration certificate Cosmetic GMP

Quick links

FDA Registration Forms

Food Facility Registration Form

Drug Registration Form

Drug Listing Form

Prior Notice Form

Medical Device Registration Form

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