Registration of Medical Device Facility and Listing of Devices.
“All information in this page are from official U.S. FDA. website.”
“Establishments that are involved in the production and distribution of medical devices intended for commercial distribution in the United States (U.S.) are required to register annually with the FDA. Most establishments that are required to register are also required to list the devices and the activities performed on those devices at that establishment” (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 Register, List and Pay the Fee”. The establishment registration fee is not eligible for a reduced small business fee.
Most establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices. If a device requires premarket approval or notification before being marketed in the U.S., then the owner/operator should also provide the FDA premarket submission number (510(k), PMA, PDP, HDE).
The amendments to the Medical Device User Fee Modernization Act require that after September 30th, 2007, all registration and listing information be submitted electronically, unless a waiver has been granted.
Registration and listing provides FDA with the location of medical device establishments and the devices manufactured at those establishments. Knowing where devices are made increases the nation’s ability to prepare for and respond to public health emergencies.
Key points
All registration holders shall pay annual fee from 1st of Otc to 31st of Dec.
All registration holders shall provide required information 1st of Otc to 31st of Dec. Organizations, that have already been registered shall review and update their registration information annually.
Foreign facility must input D-U-N-S number to finish the registration.
Regardless of the completion date of the registration process, including the payment of the registration fee, the registration information shall be renewed annually and the registration fee for the following year shall be paid in the prescribed period.
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