The US Food and Drug Administration (FDA) Requires the Appointment of a U.S. Agent for All Foreign Manufacturers

The U. S. Food and Drug Administration has published a final regulation which became effective April 26, 2002. The law now requires that all foreign manufacturers of medical devices and other FDA regulated products to designate and appoint a U.S. Agent to act as a representative for manufacturer with the FDA -- to serve as the FDA's U.S. point of contact.

The U.S. Agent must be a U.S. resident with a formal business address in the United States.

For additional information on this requirement and to avoid enforcement action by the FDA, contact us at jel@trilobyte.net.

You may review additional information on the U.S. requirements for importers on the FDA's website at U.S. AGENT FOR IMPORTERS.

Requirements for the U.S. Agent are on the FDA's website at IDENTIFYING A U.S. AGENT.

See our listing on the FDA's website under J. E. LINCOLN AND ASSOCIATES.

As a premiere U.S. Agent, J. E. Lincoln and Associates provides foreign manufacturers with just the level of service they desire depending on where they're at in the product development / marketing cycle. We bring our proven experience to meet the specific needs of your company, management team, and product(s).

Providing services for:

Anesthesiology ... Cardiovascular ... Clinical Chemistry ... Clinical Toxicology ... Dental ... Ear, Nose & Throat ... Gastroenterology & Urology ... General & Plastic Surgery ... General Hospital ... Obstetrics / Gynecology ... Ophthalmic ... Orthopedic ... Physical Medicine ... Radiology

Regional Specialization:

Asia ... Australia ... Central America ... Eastern Europe and Russia ... Mid East ... North America (Non US)... Pacific Region ... Western Europe and UK ...