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Thursday, April 14, 2011

Medical Device Import Entry Review Process


The device industry in the US continues to wonder what will become of the 510(k) process.  Senator John Kerry of Massachusetts has written a letter to FDA Commissioner Dr. Margaret Hamburg raising concerns that the medical device industry has over potential changes to the 510(k) process.  You can read more about his letter here:

FDA raised more concerns and sowed seeds of confusion in the medical device industry by publishing a letter about the import entry review process. (see  I too was confused and so contacted the Center for Device and Radiologic Health (CDRH) for clarification.  Turns out there is nothing new about the process and all that CDRH wanted to say is that imported devices can clear FDA’s border inspections faster if the paperwork includes the A of C code for the medical device being imported.

When importing a medical device into the US, the accompanying entry information should identify the product and include appropriate information to demonstrate that the product is in compliance with FDA regulations. When importing devices you must provide the following information:
  1. Foreign manufacturer number (obtained from FDA when the manufacturer registers with FDA)
  2. Listing information (Listing of the devices the company manufactures—this is done in conjunction with the registration process.)
  3. Identity of the initial importer
  4. The 510(k) or PMA number for the device

All of this information is communicated by the A of C codes and FDA’s March letter was simply trying to convey that the AofC codes are very helpful to the agency—so what is an AofC code?

AofC stands for ‘Affirmation of Compliance’.  Use of the code conveys the information listed in 1-4 above but goes further—the importer is pledging, affirming, swearing, that the product meets all FDA requirements specific to each code. So the good news is that you may be able to expedite entry of your devices into the US.  The bad news is that there are some devices that do not have AofC codes.  The codes can be found at the end of FDA’s letter.

My associates and I hope that your product is successful whether you are importing your device or manufacturing it in the US.  Contact us with your regulatory needs be it registration, listing or 510(k) or PMA submissions.

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