FDA REGISTRATION

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Food Facility Registration

This registration is required for facilities that manufacture, process, pack, or hold food products for human or animal consumption in the United States. This includes both domestic and foreign facilities.

Drug Establishment Registration

Manufacturers, repackers, relabelers, and salvagers of prescription and over-the-counter drugs are required to register their establishments with the FDA.

Medical Device Establishment Registration

All medical device establishments that develop manufacture, pack, assemble, label, export or import medical devices are required to Register with FDA.

Cosmetic Establishment Registration

Manufacturers, packers, and distributors of cosmetics intended for use in the United States are required to register their establishments with the FDA.

CATEGORIES

Food

Registration Process: Food facilities must register with the FDA using the FDA Food Facility Registration form (Form 3537). Registration must be renewed every even-numbered year, between October 1 and December 31.
Information Required: The registration form requires basic information about the facility, including its name, address, contact information, type of activity conducted, and the types of food products handled.

Foreign Facility Registration: Foreign food facilities must also register with the FDA, and they must designate a U.S. Agent for FDA Communications who serves as a contact point between the FDA and the foreign facility.

Inspection and Compliance: Registered food facilities are subject to inspection by the FDA to ensure compliance with food safety regulations, including Good Manufacturing Practices (GMP) and Hazard Analysis and Critical Control Points (HACCP).

Consequences of Non-Compliance: Failure to register a food facility or to renew registration as required by the FDA can result in regulatory action, such as detention of food products, refusal of entry into the United States, or other enforcement measures.

Comestics

Voluntary Cosmetic Registration Program (VCRP):

The FDA operates the Voluntary Cosmetic Registration Program (VCRP), which allows cosmetics manufacturers, packers, and distributors to voluntarily register their establishments and file product formulations with the FDA.

The VCRP provides the FDA with information about cosmetic products and ingredients used in cosmetics, which can be helpful for monitoring the safety of cosmetics and responding to safety concerns.

Ingredient Labeling:

Cosmetics must comply with FDA regulations regarding ingredient labeling. Manufacturers are required to list all ingredients used in the product on the label, in descending order of predominance by weight.

Drugs

Drug Listing: Manufacturers, repackers, relabelers, and private label distributors of OTC drugs are required to register their establishments and list their drug products with the FDA. This process involves submitting drug establishment registration information electronically using the FDA Unified Registration and Listing System (FURLS).

Labeling Compliance: OTC drug products must comply with FDA regulations regarding labeling, including providing accurate information about active ingredients, dosage instructions, warnings, and precautions.

OTC Monograph System: Many OTC drug products are marketed under the OTC monograph system, which establishes conditions under which certain drugs are generally recognized as safe and effective (GRASE) and not misbranded. Compliance with applicable monographs is necessary for marketing OTC drugs in the U.S.

GMP Compliance: OTC drug manufacturers are required to comply with FDA’s current Good Manufacturing Practices (cGMP) regulations to ensure the quality, purity, strength, and identity of their products.

Prescription Drugs Registration:

New Drug Application (NDA): Manufacturers seeking approval to market a new prescription drug in the U.S. must submit an NDA to the FDA. The NDA contains comprehensive data on the drug’s safety and efficacy, manufacturing processes, labeling, and proposed marketing materials.

Abbreviated New Drug Application (ANDA): Generic prescription drug manufacturers submit an ANDA to the FDA, demonstrating that the generic drug is bioequivalent to the reference listed drug (RLD) and meets applicable standards for safety, efficacy, and quality.

FDA Review: The FDA evaluates NDAs and ANDAs to determine whether the drug meets regulatory standards for approval. This evaluation includes assessing the drug’s safety and efficacy data, manufacturing processes, labeling, and proposed indications for use.

Post-Market Surveillance: Once a prescription drug is approved and marketed, the FDA continues to monitor its safety through post-market surveillance programs, adverse event reporting, and inspections of manufacturing facilities.

Medical Device

A 510(k) submission is a premarket submission made to the FDA to demonstrate that the medical device is substantially equivalent (SE) to a legally marketed device (predicate device) that is not subject to premarket approval (PMA).

The submitter compares their device to one or more predicate devices and provides evidence to support the substantial equivalence claim. This evidence typically includes performance data, device descriptions, labeling, and any necessary biocompatibility, sterilization, and software information.