Do you market or plan to export medical devices or pharmaceuticals to the United States? If so, you need to designate just one United States agent who is either a resident of the United States or maintains a place of business in the United States. This new, far reaching regulation affects any establishment within any country outside the U.S. that is engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or a device that is imported or offered for import into the United States. 

Simply stated, if your name and place of business are not registered with the FDA and do not have a designated U.S. agent, FDA and U.S. Customs will not permit your products to enter the U.S.! The final regulation implementing these requirements was published on November 27, 2001 (http://www.fda.gov/OHRMS/DOCKETS/98fr/112701a.htm).
The effective date of the regulation was February 11, 2002. It is not known whether the FDA has begun enforcement.

The responsibilities of the United States agent are limited. They include:

• assisting FDA in communications with the foreign establishment 

• responding to questions concerning the foreign establishment's products that are imported or offered for import into the United States 

• assisting FDA in scheduling inspections of the foreign establishment. 

In addition, if FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the United States agent, and such an action shall be considered to be equivalent to providing the same information or documents to the foreign establishment.

It is generally not a good idea to ask your distributor to be your agent because you may not want your distributor to know about any problems with the FDA and share confidential information. Also, you may have several distributors and want to change them. The best idea is to get someone who deals with FDA on a daily basis and can respond to FDA's questions and requests.

The regulation also states that the foreign establishment may, but is not required to, designate its United States agent as its "official correspondent". The official correspondent is the person who files the annual manufacturer registration (form 2891) and device listing (form 2892) forms. 

E-mail me if you have questions at yourFDAconsultant@medisourceasia.com 

Dr. Norman F. Estrin