Mar 25, 2011

The US FDA’s Center for Devices and Radiological Health (CDRH) has issued recommendations to improve medical device import entry review processes to expedite entry of foreign-made products into the US.

In a March 24 Letter to Industry, CDRH director of compliance Steven Silverman noted agency concerns about the number of imported medical devices lacking adequate entry data necessary for timely admission into the US by the FDA.

“These recommendations will directly impact your company’s ability to import medical devices, electronic product components, parts and finished products into the US,” writes Silverman.

The agency is seeking to speed up admittance of submissions with correct Affirmation of Compliance (AofC) data—and persuade more medical device importers to ensure that their shipments adhere to AofC requirements to avoid the need for extended FDA entry reviews.

Failure to provide adequate AofC data, Silverman advises, often results in manual reviews of product entries, causing significant delays.

Accordingly, the FDA has published new and revised AofC codes for use in transmission of medical device import entries. All entries should include AofC codes for Device Foreign Manufacturer (DEV) or Device Foreign Exporter (DFE), Device Listing (DL), Device Initial Importer (DII) and Premarket Application (PMA), which can also be a Humanitarian Device Exemption (HDE), Product Development Protocol (PDP) number, Premarket Notification Number (PMN) or Investigational Device Exemption (IDE).

Although use of the afore-mentioned codes remains voluntary, the CDRH emphasizes that their use will result in more efficient and faster reviews of imported devices.

Silverman also notes that a separate letter addressing import entry filing processes for products subject to both medical device and electronic product radiation requirements is forthcoming from the agency.

The letter advises that questions regarding the FDA’s import entry review process be sent to the CDRH’s Office of Compliance Import/Export Safety Staff at


  • Stewart Eisenhart