• Is Your Condom Compliance Safe?
  • May 2, 2013 | Author: Peter A. Quinter
  • Law Firm: GrayRobinson, P.A. - Miami Office
  • Many of you may think of a condom as a way to avoid pregnancy, but to a customs and international trade attorney, men’s latex condoms are Class II “medical devices” regulated by the U.S. Food and Drug Administration (FDA). There are several compliance issues that arise when attempting to import condoms into the United States.

    Attempting to import any medical device into the United States can be a complicated endeavor. Failure to handle these compliance matters ahead of time can lead to an FDA detention and potential FDA refusal of the shipment. U.S. Customs and Border Protection (CBP) and FDA will investigate several of these compliance requirements when your shipment arrives into the U.S., including:

    • Whether a 510(k) Premarket Notification was approved by FDA for the device;
    • Whether the importer of record filed Device Initial Importer Registration with FDA; and
    • Whether the foreign manufacturer filed the Device Facility Establishment Registration with FDA.

    With these compliance matters, cheap becomes expensive very quickly. Regulatory compliance matters are better handled before any shipments are sent.