FDA Establishment Registration for Contract Manufacturers: Everything You Need to Know
If you are in the business of manufacturing medical devices, drugs, or food products, you must be familiar with the FDA Establishment Registration. It is a mandatory requirement for all companies involved in the production and distribution of regulated products in the United States.
In this article, we will discuss FDA Establishment Registration for contract manufacturers in detail. Let`s begin with the basics.
What is FDA Establishment Registration?
The FDA Establishment Registration is a process where companies involved in the manufacturing, processing, packing, or holding of regulated products must register their facilities with the FDA. This registration process is a mandatory requirement under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
It is important to note that the FDA Establishment Registration process is not a one-time event. Companies must renew their registration annually between October 1st and December 31st each year.
Who Needs to Register with FDA?
All companies, regardless of their size or location, involved in the manufacturing, processing, packing, or holding of regulated products within the United States are required to register with the FDA. This includes domestic and foreign manufacturers, repackers, relabelers, and contract manufacturers.
What is a Contract Manufacturer?
A contract manufacturer is a company that produces goods for another company under a contract agreement. In the context of FDA Establishment Registration, a contract manufacturer is a company that produces regulated products on behalf of another company.
For example, if a medical device company outsources the production of some of its components to a third-party manufacturer, the third-party manufacturer is considered a contract manufacturer.
What are the FDA Establishment Registration Requirements for Contract Manufacturers?
Contract manufacturers must register their facilities with the FDA and comply with all applicable regulations. These regulations include, but are not limited to, the following:
1. Current Good Manufacturing Practice (CGMP) regulations
2. Labeling requirements
3. Medical Device Reporting (MDR) requirements
4. Adverse Event Reporting (AER) requirements
5. Establishment Inspections
Failure to comply with these regulations can result in serious consequences, including product recalls, fines, and legal action.
How to Register with FDA?
To register with FDA, companies must submit Form FDA 2571 electronically through the FDA Unified Registration and Listing System (FURLS). The registration process requires detailed information about the company and its facilities, such as the number of employees, production volume, type of products produced, and contact information.
Once registered, companies must keep their registration information up-to-date and renew their registration annually.
The FDA Establishment Registration is a critical requirement for companies involved in the manufacturing or distribution of regulated products in the United States. Contract manufacturers must comply with all applicable regulations and register their facilities with the FDA.
If you are a contract manufacturer seeking assistance with FDA Establishment Registration or compliance requirements, consider consulting with an experienced regulatory consultant or law firm to ensure that your company is in full compliance with all applicable regulations.