To monitor public health more effectively, the United States government has issued regulations requiring organizations that manufacture and distribute devices to register with the Food and Drug Administration.
As such, any corporation or individual looking to market a device in the United States should understand the regulations and processes involved in registration.
Requirements for Registration
Per the Food and Drug Administration Amendments Act of 2007, Title 21 Code of Federal Regulations Part 807, and authorizations of the United States Congress, domestic owners of corporations that manufacture and distribute devices, people who operate a business that manufactures devices, foreign owners who import devices, and designers are required to register their facility with and pay a fee to the Food and Drug Administration once per year.
Small businesses must pay the same fees as larger businesses.
Foreign manufacturers must also select a United States Agent to act on their behalf.
Most organizations that register with the Food and Drug Administration must also list the devices that they make and the activities that they conduct at their facilities. If the device requires a premarket approval or a 510(k) Premarket Notification, the organization should also provide the premarket submission number.
The Medical Device Registration Process: General Considerations
In order to register, the owners of an organization must complete two steps:
First, they must pay the annual fee. This annual fee can be paid electronically via the Device Facility User Fee website. After they pay the annual fee, they will receive a payment identification number.
The Food and Drug Administration also will send information on how to obtain a payment confirmation number via e-mail once the payment has cleared. Owners cannot proceed with registration until they have received this payment confirmation number.
Then they should submit the annual registration and listing information electronically via the Food and Drug Administration's Unified Registration and Listing System/Device Registration and Listing Module.
Each owner or operator must have an account identification and password to use the listing system. If the owner or operator has chosen another person to act as an official correspondent, the owner must create a subaccount that includes a separate identification and password for that person.
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