FDA Facility Registration Requirements

Overview of When Registration is Required

FDA facility registration requirements vary depending on the FDA regulated product marketed and sold. Various types of FDA facility registration are discussed in the sections below. In general prior to entering the market a company must classify the product, determine if FDA approval is required before marketing and selling, and register with the FDA prior to any marketing or sales.

The FDA facility registration requirements vary by facility type. The three most common registrations are: food/supplement, medical device, and drug. All food, dietary supplement, medical device and drug (OTC, Rx, and Homeopathic) facilities are required to register with the FDA. FDA Blood Establishment Registration is often overlooked, but is mandatory (click here to learn more). Cosmetic registration, however,  is voluntary.

The FDA Facility registration requirements for food require a bi-annual registration for food (human and animal) and supplement companies. Importers, distributors, manufacturers, relabelers and repackagers are among the groups required to register.

FDA facility registration requirements for low acid or acidified canned foods (LACF) is a special form of food registration. It is more involved and requires process validation by the FDA.

The FDA facility registration requirements for medical devices includes an annual registration based on the FDA fiscal year. The fiscal year runs from October 1 through September 31. There is an annual fee for medical device registration and it also requires appropriate device approval.

The FDA facility registration requirements for drug are among the most robust. It requires establishment registration and drug listing. In many cases this also involves requesting a National Drug Code (NDC).

Finally New Tobacco Products involve approval and registration with the FDA.

Review the information below for more information on FDA facility registration requirements. Also below there are sample certificates provided by the firm. Contact our Washington D.C. or Charlotte offices with questions about FDA registration requirements.

Sample Certificates
Sample Food Facility Registration Certificate.
Sample Medical Device Establishment and Device Listing Certificate.
Not Sure if You Need to Register - Learn More about FDA Registration