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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 OTC 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 OTC 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.
There are NO extra charges. Our Registration Processing and US Agent fee is one simple, flat fee.
There are NO extra 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
Same-Day service if available at NO extra charge.
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 US FDA Registration Number (for Food, Beverage, Medical Devices, or oTC Drug Products, this Number must be given on every prior notice of 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 Food,Medical Device or OTC Drug Facilities, confidentially.
- We watch over the registration laws and regulations and let you know if there is anything new that might affect your business.
- 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 |
includes Registration Processing, US FDA Registration Number Notification, Product Listing
US Agent services, and confirmation Certificate of Registration for your records (249 annual US Agent renewal total) |
| Each FOREIGN MEDICAL Facility; |
499 |
includes Registration Processing, US FDA Registration Number Notification, Product Classifications
US Agent services and Medical Device Listings for all your Products (349 annual FDA Registration and US Agent renewal total) |
| Each DOMESTIC Food Facility: |
129 |
includes Registration Processing, US FDA Registration Number Notification, Product Listing
and Confirmation of Registration for your records;one-time fee |
| Each DOMESTIC Medical Device facility:nd th |
349 |
includes Registration Processing, US FDA Registration Number Notification, Product Classifications
and Medical Device Listings for all your Products (249 annual renewal total)
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| Each OTC 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 |
| Changes/Amendments to Registration: |
FREE! |
FREE changes/amendments for our clients |
| Medical Device Listing: |
FREE! |
FREE! No charge for Product Classification for all your Medical Devices,
no matter how many you have |
* 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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