Device Registration and Listing

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 (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.

The schedule of annual registration user fees for fiscal years 2013 through 2017 follows:

Year	FY 2013	FY 2014	FY 2015	FY 2016	FY 2017
Fee	$2,575	$3,313	$3,636	$3,872	$3,382

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.

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If you encounter an issue during the registration and listing process and need to contact us, please fill out as much of the information below as possible.

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*Name:

Business Name:

*Email Address:

Phone Number:

Best Time to Reach You (please include your time zone):

Establishment Registration Number (unless one is not assigned):

*Is this an initial registration or are you updating an existing registration or listing?

Initial Registration

Updating Existing

*Business Name of Your Establishment:

Address of Establishment:

Owner/Operator Number for the Establishment:

Payment Identification Number (PIN):

Payment Confirmation Number (PCN):

DUNS Number:

*Please enter a brief summary of the issue you encountered. If you are seeing an error message while in the registration website, please identify what the error message said and the action you were attempting at the time.

Medical Devices

Device Registration and Listing

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