US Agent

Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States must identify a United States agent (U.S. agent) for that establishment.

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:

  • assisting FDA in communications with the foreign establishment,
  • responding to questions concerning the foreign establishment’s devices that are imported or offered for import into the United States,
  • assisting FDA in scheduling inspections of the foreign establishment and
  • 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.

LabTest USA will provide you with a service of representing your company in the United States.

Get A Quote Now

Labtest-USA has more than 15 years of experience helping our clients around the world process and obtain any type of USA certifications.

  • NFast terms
  • NThe best specialists in the state
  • NWe work all over the world
  • NWe work in many directions
  • NQuality assurance
Opening Hours
We work seven days a week and will always give quick feedback to our clients
Monday
10.00 - 18.00
Tuesday
10.00 - 18.00
Wednesday
10.00 - 18.00
Thursday
10.00 - 18.00
Friday
10.00 - 18.00
Saturday
10.00 - 18.00
Sunday
10.00 - 18.00
Best Value
  • AOwner operated, low overhead
  • ALow, flat fees
  • ANo hidden costs
Professional
  • A15+ years experience
  • ABBB A+ rating
  • ANo high pressure sales
Personal Attention
  • ASolutions customized to you
  • AWork directly with owners
  • AExtensive referral network
Contacts

 33024 Hollywood,FL

Phone:
+1-786-9096695

Email:
Info@labtest-usa.com