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Your U.S. FDA
Agent
You’re Business
Success Starts
Here!!
Buyers, Sellers, Traders for
Your Business
Need FDA
Approval for your Product??
To market your products in the
United States, you will need
clearance by the FDA. Registering with the FDA is only part
of the process. The FDA requires that you have a U.S. Agent
to act as your communicator between the FDA and you. We will
be your U.S. Agent.
1.
We will determine if
your product needs FDA Approval.
2.
We will search for
similar FDA approved products and determine its Regulation
Number and Classification Product Code.
3.
We will use your
Product Classification Code and determine whether any Standards
and/or Guidance documents apply to your
device.
4.
After your product
has been identified, we will prepare and submit a 510(k)
application to the FDA. (note: the FDA charges a fee to review
your application?
5.
The FDA will then
review your application, which will be reviewed within 90 days.
If it is
successful, you will receive a 510(k) clearance letter from the
FDA with your 510(k) number.
6.
We will register your
device and company with the FDA with your 510(k) number. (Note:
the FDA has an annual registration fee)
7.
Once your forms are
submitted and fees are paid, your are cleared to sell in the
USA.
8.
We then act as a
liaison between your company and the FDA, responding to
questions concerning your products and assist you and the FDA
to schedule inspections, if needed.
9.
We ensure that all
regulatory responsibilities and interests of our clients are
handled professionally, confidentially and
promptly.
Our responsibilities are
listed below.
Contact us at www.americatradesite.com
or americatradesite@gmail.com to begin the process.
Responsibilities of a
U.S. Agent
The U.S. agent
must either reside in the U.S. or maintain a place of
business in the U.S. The U.S. agent cannot use a post
office box as an address. The U.S. agent cannot use just
an answering service. They must be available to answer the
phone or have an employee available to answer the phone during
normal business hours.
The responsibilities
of the U.S. agent are limited and
include:
1.
assisting FDA in communications with
the foreign establishment,
2.
responding to questions concerning
the foreign establishment's devices that are imported or
offered for import into the United States,
3.
assisting FDA in scheduling
inspections of the foreign establishment and
4.
if FDA is unable to contact the
foreign establishment directly or expeditiously, FDA may
provide information or documents to the U.S. agent, and
such an action shall be considered to be equivalent to
providing the same information or documents to the foreign
establishment.
·
Please note that the
U.S. agent has no responsibility related to reporting of
adverse events under the Medical Device Reporting regulation
(21 CFR Part 803), or submitting 510(k) Premarket Notifications
(21 CFR Part 807, Subpart E)
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