The US FDA’s Center for Devices and Radiological Health (CDRH) has issued an update to its Letter to Industry about Import Entry Review Process from March 2011 specifying which Affirmation if Compliance (AofC) codes to use for radiation-emitting medical devices imported into the US market.
Using correct AofC codes can help ensure that medical device imports are not held up for further FDA entry review prior to distribution, marketing and sales in the US, according to the new CDRH letter. Medical device manufacturers as well as their importing and distribution partners shipping radiation-emitting electronic medical devices should adjust their processes accordingly to avoid US market entry delays.
Radiation-emitting electronic products, many of which have medical technology applications, are subject to US federal performance standards and regulated by CDRH, 21 CFR Parts 1000-1005 and US Customs and Border Protection (CBP) regulations 19 CFR 12.91. Such products include video display monitors using cathode ray tubes, diagnostic x-ray systems and components, laser products and ultrasonic therapy systems.
Importers of any radiation-emitting electrical products subject to federal performance standards must submit information for each shipment to both the FDA and CBP, and affirm whether their products comply with performance standards.
Radiation-emitting electronic medical devices subject to federal performance standards must submit appropriate AofC codes listed in the FDA’s March 24, 2011 letter as well as AofC codes applicable to both medical devices and radiation-emitting electrical products provided in the new notice:
|Medical Device AofC Codes||Electronic Product Radiation Control AofC Codes|
|• Device Foreign Manufacturer (DEV) or Device Foreign Exporter (DFE)||• EPRC Accession Number (ACC) or EPRC Annual Report Number (ANC)|
|• Device Listing (LST)||• EPRC Model Number (MDL)|
|• Device Initial Importer (DII)||• Affirmation code from Form FDA-2877|
|• Premarket Application (PMA), Premarket Notification Number (PMN) or Investigational Device Exemption (IDE)||
Questions regarding AofC codes and the US import entry review process should be addressed to the CDRH Office of Compliance Import/Export Safety Staff: cdrhocimport [at] fda [dot] hhs [dot] gov, with the subject line “EPRC Inquiries.”