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Home › Fees › Medical Devices |
Fees
The following chart provides a detailed breakdown of the fee structure for our Medical Device services:
| Description of Services |
If you are an Initial Distributor/Importer * |
If you are not an Initial Distributor/Importer ** |
| Medical Device Facility Registration |
$150 USD per Facility
One-Time Fee |
$150 USD per Facility
One-Time Fee |
|
Medical Device Listing Fee |
Not Required |
$195 USD Per Device
One-Time Fee |
|
U.S. Agent and Correspondent Fee |
$645 USD
Annual Fee |
$645 USD
Annual Fee |
| Label Reviews |
$995 USD per Device |
$995 USD per Device |
* Initial Distributor/Importer - Takes first title to devices imported into the U.S. An Initial Distributor must have a U.S. address.
** If you fall under one or more of the following categories, you are required to List each of your Devices with FDA:
Contract Manufacturer - Manufactures a finished device in accordance with another establishment's specifications and puts the device in commercial distribution.
Contract Sterilizer - Provides a sterilization service for another establishment's devices and puts the devices in commercial distribution.
Foreign Exporter - Exports or offers for export to the United States, a device manufactured or processed by another individual, partnership, corporation or association in a foreign country, including devices originally manufactured in the United States. A foreign exporter must have an establishment address outside the U.S.
Manufacturer - Makes by chemical, physical, biological, or other procedures, any medical instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article.
Remanufacturer - Processes, conditions, renovates, restores, or does any other act to a finished device that significantly changes the finished device's performance or safety specifications, or in any way changes the intended use.
Repackager - Packages finished devices from bulk or repackages devices made by a manufacturer into different containers (excluding shipping containers).
Relabeler - Changes the content of the labeling from that supplied from the original manufacturer for distribution under the establishment's own name. A relabeler does not include establishments that do not change the original labeling but merely add their own name.
Reprocessor of Single Use Devices - Performs remanufacturing operations on a single use device.
Specification Developer - Develops specifications for a device that is distributed under the establishment's own name but performs no manufacturing. This includes establishments that, in addition to developing specifications, also arrange for the manufacturing of devices labeled with another establishment's name by a contract manufacturer.
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