(World Trade Interactive)
The Food and Drug Administration issued this week a letter providing specific recommendations to facilitate the FDA import entry review process for medical and non-medical radiation-emitting electronic products. This letter describes the affirmation of compliance (AofC) codes that can be provided at the time of entry to help expedite the admissibility process. FDA states that appropriately-submitted AofC codes increase the likelihood that a shipment will not be held for further review during FDA’s import screening process.
According to FDA, the following radiation-emitting electronic products are subject to a federal performance standard: television receivers and video display monitors with cathode ray tubes only, diagnostic x-ray systems and their major components, cabinet x-ray systems, microwave ovens, laser products (includes laser pointers, laser light shows, industrial lasers, medical lasers, and surveying, leveling and alignment lasers), sunlamp products and ultraviolet lamps intended for use in sunlamp products, high-intensity mercury vapor discharge lamps, and ultrasonic therapy products.
Importers of these products must submit information on each product shipment to FDA and U.S. Customs and Border Protection. CBP regulations require importers to affirm that products they are importing comply or do not comply with federal performance standards. FDA works with CPB by providing form FDA-2877, Declaration for Imported Electronic Products Subject to Radiation Control Standards, which must be completed by the importer and can be found here.
FDA notes that there are medical radiation-emitting electronic products, such as radiation therapy devices, linear accelerators, diagnostic ultrasounds for imaging, microwave diathermy, shortwave diathermy, hearing aids, cardiac radiofrequency ablation devices and extracorporeal shock wave lithotripters, that may have reporting requirements in 21 CFR 1002 but are not subject to federal performance standards. In these cases, form FDA-2877 is not required.
To help expedite the FDA electronic screening process for medical devices that are also radiation-emitting electronic products, each entry line should contain AofC codes applicable to both medical devices and radiation-emitting electronic products.
MEDICAL DEVICE RELATED CODES
Device Foreign Manufacturer (DEV) or Device Foreign Exporter (DFE)
Device Listing (LST)
Device Initial Importer (DII)
Premarket Application (PMA) [can be a PMA, a Humanitarian Device Exemption (HDE) or a Product Development Protocol (PDP) number]
OR a Premarket Notification Number (PMN)
OR an Investigational Device Exemption (IDE)
ELECTRONIC PRODUCT RADIATION CONTROL RELATED CODES
EPRC Accession Number (ACC)
Or EPRC Annual Report Number (ANC)
EPRC Model Number (MDL)
AofC code from form FDA-2877
To help expedite the FDA electronic screening process for non-medical radiation-emitting electronic products, each entry line that is subject to federal performance standards should contain an AofC code related to the appropriate form FDA-2877 declaration and, if appropriate, should contain AofC codes ACC or ANC.
[The September 6, 2011, Letter to Industry about Import Entry Review Process is available here.]
Date: September 9, 2011