What is FDA Establishment Registration?

Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States (U.S.) are required to register annually with the FDA. This process is known as establishment registration.

How is the FDA divided?

It consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations.

How much does FDA registration cost?

Annual Establishment Registration Fee: $5,546 All establishments must pay the establishment registration fee. There are no waivers or reductions for small establishments, businesses, or groups.

How to register a drug establishment with the FDA?

Our Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing (PDF – 123KB) and accompanying technical documents describe how to make these submissions using the SPL format, which FDA can process, review, and archive.

How does the FDA collect device registration fees?

This process is known as establishment registration ( Title 21 CFR Part 807 ). Congress has authorized FDA to collect an annual establishment registration fee for device establishments. A detailed list of the types of device establishments that are required to register and pay the fee can be found at ” Who Must…

When does an establishment get removed from the FDA Database?

Any establishment is automatically removed from the database if its registration is inactivated by FDA due to a compliance case. Registrations that expire, deregister or are otherwise dropped from submission are also removed from the database. Establishments must be registered within five days of beginning operations.

How to register a tobacco product with the FDA?

FDA strongly encourages electronic submission. For electronic submission of such information, FDA utilizes the Tobacco Registration and Product Listing Module – Next Generation (TRLM NG). Alternatively, you may use Form FDA 3741 for Establishment Registration and Product Listing.