Mar 25, 2011

The FDA's Center for Devices and Radiological Health (CDRH) has published a Letter to Industry dated 24 March 2011 outlining information importers should provide to ensure expedited entry of their products into the US market. The letter and other detailed information about the FDA import review process is available on the FDA website.

"These recommendations will directly impact your company's ability to import medical devices, electronic product components, parts and finished products into the US," states the letter.

Specifically, the FDA recommends better adherence by importers to correct Affirmation of Compliance (AofC) data in order to avoid significant entry delays. An appendix of medical device AofC codes has been included with the FDA's Letter to Industry.

When a product enters the United States, medical device importers should make sure to include AofC codes for the following information:

  • Device Foreign Manufacturer (DEV) or Device Foreign Exporter (DFE)
  • Device Listing (LST)
  • Device Initial Importer (DII)
  • Premarket Notification (PMN) 510(k) number, if relevant
  • Investigational Device Exemption (IDE)

The agency emphasizes that although use of AofC codes remains voluntary, firms that do make use of them greatly increase their chances of having their devices cleared for import entry faster.

A separate Letter to Industry focusing on the import entry filing process for medical devices that also qualify as electronic radiation products is forthcoming, according to the CDRH.

Any questions regarding the FDA’s import entry review process should be sent to the CDRH’s Office of Compliance Import/Export Safety Staff at


  • Stewart Eisenhart