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| What the Law requires: |
As a Domestic (in the U.S.) or Foreign (outside the U.S.) Food, Beverage,Medical Device or Drug 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, Medical Device or Drug Facility; and
- Notify the FDA of any changes of your information.
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The fees below are very simple and easy to understand. Our fees are flat fees, and sometimes almost one-half what other companies charge for the same service.
There are NO extra charges. Our Registration Processing, Product or Device Listing and US Agent fee is one simple, flat fee, with NO extra charges for food products or your first ten medical devices
There are NO extra charges for any of your food or beverage products or your first ten exempt Medical Device Listings (35 usd/per after ten).
* * (Some others charge you 195 usd for each medical device!)
FDA Agents provides you with a FREE confirmation Certificate of US FDA Registration for your records with all the pertinent information (Some others might charge up to 89 usd!), and
Same-Day service if available at NO extra charge.
Files any changes and amendments, always free of charge.
| What we do: |
At FDA Agents:
- 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, provide you Confirmation and advise you of your US FDA Registration Number if applicable (for Food, Beverage, Medical Devices, or Drug Products, this Number must be given on every shipment of your products into the United States).
- If there are any corrections needed, we work with you to correct any deficiencies.
- We serve as your required U.S. Agent for Foreign Medical Device or Drug Facilities,and Agent-compliance for food facilities is provided by US Agent Service, and all is done confidentially.
- Your U.S. Agent interacts between the FDA and you 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 |
includes Registration Processing, US FDA Registration Number Notification, Product Listing
your US Agent designation of US Agent Service, and confirmation Certificate of Registration for your records. (Some others charge you 690 usd!) The annual-rolling twelve months-renewal fee is 289 usd. (Some others charge you 495 usd!) |
| Each FOREIGN MEDICAL Facility; |
499 |
includes Registration Processing, US FDA Registration Number Notification, Product Classifications
US Agent designation and Medical Device Listings for your first ten Products (35 usd/per after ten), and only 389 annual FDA Registration
and US Agent renewal total. (Some others charge you 695 usd each year and charge you 195 usd for each device!) |
| Each DOMESTIC Food Facility: |
129 |
includes Registration Processing, US FDA Registration Number Notification, Product Listing
and Confirmation of Registration for your records; 129 usd renewal once every two years |
| Each DOMESTIC Medical Device facility:nd th |
349 |
includes Registration Processing, US FDA Registration Number Notification, Product Classifications
and Medical Device Listings for your first ten Devices (35 usd/each after ten), with only a 289 annual renewal
total. (Some others charge you 695 us annually and 195 usd for each device!)
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| Each Drug Company: |
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Please send an email to info@fdaagents.com and tell us your type of products and how many different ones you have |
| confirmation Certificate of Registration: |
FREE! |
FREE confirmation Certificate of US FDA Registration for your records. (Some others might charge you 89 usd for this Certificate! Our Certificate is free.) |
| Changes/Amendments to Registration: |
FREE! |
FREE changes/amendments for our clients |
| Medical Device Listing: |
FREE! |
FREE! No charge for FDA required Classification of all your Medical Devices,
at no charge for your first ten devices (35 usd/per after ten).
(Some others charge you 195 usd for each device! We charge nothing for your first ten devices, saving you almost 2,000 usd.) |
* All fees are in U.S. Dollars
** FDA Agents is not a part of, or affiliated with, the United
States Government or the Food and Drug Administration.**
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