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

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

The U.S. Agent must be a U.S. resident with a formal business address in the United States, and cannot use a Post Office Box.  We offer that capability. 

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

You may review additional information on the U.S. requirements for importers on the FDA's website www.fda.gov at U.S. Agent .

As a U.S. Agent, J. E. Lincoln and Associates LLC 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).

There is a low monthly fee, payable annually (USD) prior to start.  Fees vary according to the level of service desired.  Currently our "bare bones" contact service is $60.00 / month, payable $720.00 / year in advance (USD).

$720.00 (USD) for our basic service (one year) -- a written agreement, terms / conditions, and the address to be supplied to the U.S. FDA will be provided.