United States Agent

FDA requires all foreign medical device companies to enlist a United States Agent residing in the U.S.  Details pertaining to this regulation are found on FDA’s website at  http://www.fda.gov/OHRMS/DOCKETS/98fr/112701a.htm. 

At the present time, Regulatory Insight is acting as United States Agent for over 100 foreign companies.  It has been our experience that foreign companies can have different sets of needs from a United States Agent; therefore, we offer a couple of different packages to fit these differing needs.

Please contact us to find out which of Regulatory Insight, Inc.’s packages best fits your company’s needs from a United States Agent.