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FDA Registration Number - FDA Requirements

Manufacturers and distributors who plan to market their products in the USA most often recognize that FDA registration number is a mandatory requirement, but 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 are not complying with these requirements FDA may detain the product or may consider it as misbranded. FDA Registration is not a mandatory requirement for cosmetic products. For drug and medical device FDA registration is mandatory but registration number (FEI) is not compulsory.

Below table provide you a brief description of FDA requirements for each product categories

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 can register voluntarily.

Label Compliance

Ingredient compliance

GMP Compliance

Cosmetic Regulations

Cosmetic registration certificate

Cosmetic GMP


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