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Datamyne Blog

Covering trade & transport, with tips on using import-export data to advantage

Prophylactic Compliance

Category: Imports, Trade Policy

What you need to do before importing condoms – or any other Class II medical device – to the US | by Peter Quinter, guest columnist

Many of you may think of a condom as a way to avoid pregnancy and protect against sexually transmitted diseases.

But to a customs and international trade attorney, men’s latex condoms are Class II “medical devices” subject to US Food and Drug Administration (FDA) regulation – which makes importing them into the US a complicated endeavor.

For a shipment of condoms – or any Class II medical devices – coming into the US, Customs and Border Protection (CBP) and the FDA will want to see that

  • a 510(k) Premarket Notification for the devices has been approved by FDA,
  • the importer of record has filed a Device Initial Importer Registration with FDA, and
  • the foreign manufacturer has filed a Device Facility Establishment Registration with FDA.

Effective January 1, 2013, two more requirements have been added:

  • an electronic copy (eCopy) of the Premarket Submission (that is the 510(k) and Premarket Approval applications) must have been validated by FDA’s eCopy loading system, and
  • the eCopy must be accompanied by a hardcopy of the Premarket Submission documents along with a signed cover letter that states “This eCopy is an exact duplicate of the paper copy.”

The eCopy may be a compact disc (CD), digital video disc (DVD), or a flash drive.

Applications to the FDA that are not submitted in eCopy and hardcopy with the cover letter will be rejected.

With these compliance matters, cutting corners becomes expensive very quickly. Failure to comply fully ahead of time – before your shipment arrives in port – can result in the FDA’s stopping it from getting any further.

For more information on importing medical devices to the US, visit the FDA website.

Please call or email me with any questions or comments at [email protected] or (954) 270-1864.

Copyright © 2013 GrayRobinson

Join Peter Quinter at next week’s Export Compliance Bootcamp, presented by the US Commercial Service and the Florida District Export Council. Among the topics covered: export licenses, Export Administration Regulations (EAR), AES requirements, voluntary self-disclosures, and more. Wednesday, May 29, 8:00 a.m. to 5:00 p.m., St. Petersburg College’s EpiCenter, Clearwater, Fla. Learn more / register here.

About Peter Quinter

Peter Quinter, GrayRobinsonThe Datamyne Blog’s legal contributor is a shareholder in GrayRobinson’s Miami and Ft. Lauderdale offices, chair of the Customs & International Trade Law Group, and editor of the GrayRobinson Customs and International Law Blog. Appointed by the Secretary of Commerce to the Florida District Export Council, Quinter is a recognized expert in international and trade law: Florida Trend magazine ranks Quinter among its “Legal Elite” in International Law; he is listed in “Best Lawyers in America” in the area of FDA Law.

The opinions expressed in this article are those of its author and do not purport to reflect the opinions or views or Descartes Datamyne. In addition, this article is for general information purposes only and it’s not intended to provide legal advice or opinions of any kind and my not be used for professional or commercial purposes. No one should act, or refrain from acting, based solely on this article without first seeking appropriate legal or other professional advice.

Date posted: May 22, 2013

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