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| What the Law requires: |
As a Domestic (in the U.S.) or Foreign (outside the U.S.) Food, Beverage or Medical Device Facility, you have to:
- Register with the United States Food and Drug Administration (the "FDA");
- Appoint a Qualified U.S. Agent if you are a Foreign Food, Beverage or Medical Device Facility; and
- Notify the FDA of any changes of your status.
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The fees below are very simple and easy to understand.
There are NO extra charges. Our registration/US Agent fee is a simple, flat fee.
There are NO charges for any of your food or beverage products or your exempt Medical Device Listings, no matter how many you have.
FDA Agents provides you with a FREE confirmation Certificate of US FDA Registration for your records with all the pertinent information, and
Files any changes and amendments, always free of charge.
| What we do: |
As your U.S. Agent:
- We process the FDA Registration Form and register your Company with the United States Food and Drug Administration (the "FDA").
- We notify you when the Registration is accepted and advise you of your FDA Registration Number (for Food, this Number must be given on every prior notice of every single international export shipment of your products into the United States).
- If there are any corrections needed, we notify you of what deficiencies need to be corrected.
- We serve as your required U.S. Agent for Foreign Food or Medical Facilities, confidentially.
- We interact between the FDA and you as your U.S. Agent for all official and required communications.
- We file changes and amendments, as needed, free of charge.
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| Our Fees: |
U.S. FDA REGISTRATION PROCESSING AND U.S. AGENT REPRESENTATION:
| Each FOREIGN FOOD Facility: |
$ 389.00 |
includes Registration Processing, US FDA Registration Number Notification,
US Agent services, and confirmation Certificate of Registration for your records (249 annual US Agent renewal total) |
| Each FOREIGN MEDICAL Facility; |
$ 499.00 |
includes Registration Processing, US FDA Registration Number Notification,
US Agent services and exempt Medical Device Listings for all your Products (349 annual US Agent renewal total) |
| Each DOMESTIC Food Facility: |
$ 79.00 |
one-time fee (no U.S. Agent required) |
| Each DOMESTIC Medical Device facility:nd th |
$ 299.00 |
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| confirmation Certificate of Registration: |
$ FREE! |
FREE confirmation Certificate of US FDA Registration for your records |
| Changes/Amendments to Registration: |
$ FREE! |
FREE changes/amendments for our clients |
| Medical Device Listing: |
$ FREE! |
FREE! No charge for any of your exempt Medical Devices,
no matter how many you have |
* All fees are in U.S. Dollars
** FDA Agents, Inc., is not a part of, or affiliated with, the United
States Government or the Food and Drug Administration.**
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