FDA AGENT

The U.S. Food & Drug Administration (FDA) requires that any registered foreign establishment engaged in the manufacture, sale, or processing of a device imported into the U.S. must identify a U.S. agent during registration.

NAVIGO will help you comply with Federal Regulations and FDA registration. We will guide you through the registration process and are available as your FDA Agent. Such Agent must reside in the U.S. and be available to answer the phone during normal business hours.

The responsibilities of NAVIGO as your FDA Agent include:

  • Assisting the FDA in communications with your Headquarters
  • Responding to questions concerning the registered products that are imported into the U.S.
  • Assisting the FDA in scheduling inspections
  • Acting as your domestic communications representative in the U.S.

The Information about foreign establishment’s is submitted electronically during registration with the FDA. You may designate only one U.S. agent and need to do so before finalizing the registration process. Do not wait to contact us to discuss any details.

The scope of FDA’s authority is broad and includes those of several other government agencies. The following is a list of product categories that generally fall under FDA’s jurisdiction: 

Drugs

  • prescription drugs
  • non-prescription drugs

 

Biologics

  • vaccines
  • blood and blood products
  • cellular and gene therapy products
  • tissue and tissue products
  • allergenics

 

Electronic Products (radiating)

  • microwave ovens
  • x-ray equipment
  • laser products
  • ultrasonic therapy equipment
  • mercury vapor lamps
  • sunlamps

 

Tobacco Products

  • cigarettes
  • cigarette tobacco
  • roll-your-own tobacco
  • smokeless tobacco

Foods

  • dietary supplements
  • bottled water
  • food additives
  • infant formulas
  • other food products (U.S. Department of Agriculture regulates meat, poultry, and egg products)

 

Medical Devices

  • simple items like tongue depressors and bedpans
  • complex technologies such as heart pacemakers
  • dental devices
  • surgical implants and prosthetics

 

COSMETICS

  • color additives found in makeup and other personal care products
  • skin moisturizers and cleansers
  • nail polish and perfume

 

Veterinary Products

  • livestock feeds
  • pet foods
  • veterinary drugs and devices