Before they can be made available to consumers in the United States, certain products need to be certified by the United States Food and Drug Administration (FDA). This is to ensure that the products comply with the FDA’s health and safety standards. Products subject to FDA registration are consumable products and products that can enter the body in other ways, such as topical cosmetics and medical devices.
The FDA, a federal agency that operates within the United States Department of Health and Human Services, was created in 1906 to oversee the manufacture and distribution of consumable products in the United States. The agency was started through the passing of the Pure Food and Drug Act. This law was enacted in response to public backlash against dirty and unsafe conditions in the Union Stockyards, a Chicago transit and storage hub that served as the center of the U.S. meatpacking industry.
FDA Registration Requirements
Every company that manufactures or sells these products in the U.S. must be registered with the FDA, regardless of whether they are based in the United States or not. This includes companies that repack and relabel products in categories covered by the FDA. There are a variety of reasons why an individual or company would want to conduct an FDA facility registration number lookup, such as to verify that a vendor is, in fact, registered with the FDA and to ensure that a facility is in compliance with FDA standards.
The Purpose of an FDA Registration Number
An FDA registration number is used to note that a product manufacturer is in compliance with the FDA’s health and safety guidelines for the product it manufactures. Assigning each registered manufacturer a registration number makes it easy to conduct an FDA facility registration number lookup in the appropriate FDA registration database to determine whether a specific manufacturer is registered and in compliance.
The process for assigning registration numbers varies from product category to product category. For food manufacturers, FDA registration is mandatory, and a registration number is issued as soon as the facility is registered with the FDA. For facilities that manufacture drugs and medical devices, an FDA registration number is issued within 90 days of completing registration.
FDA Registration and Approval
Although the term “FDA approved” is often used in colloquial conversation, it is not always an accurate way to describe FDA-registered businesses. While the FDA maintains specific health and safety guidelines for the manufacture of various product categories, how it enforces these guidelines varies from category to category. One category that clearly illustrates the limits of FDA registration is the manufacture of pharmaceutical drugs.
Before a pharmaceutical drug or biologic may become commercially available across multiple states, it must be able to meet the FDA’s safety and effectiveness requirements for drugs and biologics. Similarly, the product’s manufacturer must demonstrate that the product was manufactured according to FDA safety regulations. But a compounded drug, a drug customized for an individual patient by a compounding pharmacy, is not held to any specific FDA requirements. Similarly, the facilities that manufacture drugs and biologics are not approved by the FDA, but they are registered with it and required to comply with its manufacturing specifications.
In contrast, tobacco products are handled very differently by the FDA. To be legally permitted to sell or distribute new tobacco products in the United States, a manufacturer must be granted a written order to do so by the FDA. This may be granted after the manufacturer submits a Premarket Tobacco Product Application or a Substantial Equivalence Application, both of which are issued only after the new product is deemed to be in compliance with the FDA’s public health standards for tobacco products.
Which Products Need FDA Registration Numbers?
Manufacturers of products in the following categories must register with the FDA on a yearly basis:
- Animal-derived human and veterinary drugs.
- Food products.
- Medical devices.
- Blood products and other biologicals.
- Tobacco products.
- Pharmaceutical drugs.
- Radiation-emitting devices.
There is one exception to this requirement. Companies that manufacture, repackage or relabel cosmetics are not required to register with the FDA, but they may do so voluntarily. The FDA’s program for registering cosmetics is called the Voluntary Cosmetic Registration Program (VCRP). This program employs a post-market reporting system, which means products are tracked after hitting the market, and if problems with them are reported to the FDA, they may be reviewed and potentially recalled.
Registration requirements vary by product category. By registering with the FDA, a company consents to inspections by FDA representatives to ensure that it’s in compliance with FDA regulations.
Other FDA Identification Numbers
An FDA registration number is not the only type of certification number the FDA issues. Products in certain categories are issued other identifying numbers at various points in their journey from the date they were introduced to the FDA to the time they reach the consumer market. One example is the 510(k) number, an identifying number issued to medical devices that have been submitted to the FDA asserting that they are at least equally as safe and effective as similar medical devices currently on the market.
The FDA also issues accession numbers to reports on electronic products. Before a radiation-emitting device can be approved by the FDA, its manufacturer must maintain records of the product’s specifications and capabilities and file reports about the product with the FDA’s Center for Devices and Radiological Health (CDRH). Once a report is filed, it is issued an FDA accession number. This is the number by which the report is then tracked and organized within the FDA’s database of reports on radiation-emitting products, including laser lights, X-rays, microwaves and radios.
Looking up an FDA accession number is similar to searching for an FDA facility registration number. They can be accessed through the FDA’s website and the database for reports on radiation-emitting devices.
Searching for an FDA Registration Number
The FDA maintains multiple online databases of all its current manufacturer registration numbers. These databases can be accessed through the FDA’s website. To find a specific manufacturer’s FDA registration number, go to the database that contains its industry’s registrations. For example, if you’re looking for a drug manufacturer’s registration number, you need to search the FDA’s database of drug establishment registrations.
Not all categories’ facility registration databases are publicly accessible, though. The food, dietary supplement and cosmetic FDA registration databases are confidential. Food facility owners can contact the FDA directly to find out their registration numbers and all other details related to their registration.
To find a manufacturing facility’s FDA registration number in one of the publicly accessible databases, you need to provide information about the company for which you are conducting the FDA facility registration number lookup, such as the facility’s trade name, the product name for a specific product, and the name of the facility’s owner or operator. Other information that can be useful in this type of search include the state in which the facility is located, the type of establishment it is, and if the company is based outside of the United States, its country of origin.
Lindsay Kramer is a freelance writer and editor who has been working in the legal niche since 2012. Her primary focus areas within this niche are family law and personal injury law. Lindsay works closely with a few legal marketing agencies, providing blog posts, website content and marketing materials to law firms across the United States.