FDA update September 9, 2011

Letter to Industry about Import Entry Review Process (September 6, 2011)

IMPORTANT LETTER TO IMPORTERS AND EXPORTERS

This is a follow up to the United States Food and Drug Administration’s (FDA) medical device Letter to Industry about Import Entry Review Process, dated March 24, 2011.

The purpose of this follow up letter is to provide 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 import entry to help expedite the admissibility process. Appropriately-submitted AofC codes increase the likelihood that your shipment will not be held for further FDA entry review during FDA’s import screening process. It is essential that the appropriate personnel associated with the import process (e.g., regulatory affairs staff, import personnel, brokers/filers, etc.) receive and understand this notification and that your company’s procedures are updated accordingly.

Importers must work closely with their import personnel (brokers/filers) to verify that information submitted is correct to ensure the highest level of data quality. For the review of entries to be as expeditious as possible, consistent and accurate identifiers for firms and correct product codes for the products being imported must be submitted. Inaccurate or inconsistent data may lead to delays. Additionally, we encourage submission of AofC codes along with their appropriate qualifier. The submission of accurate entry data and AofC codes will help expedite the entry review process and increase the likelihood that your shipment will be processed based on import system screening and that it will not be held for further review.

The products listed below are subject to a federal performance standard:

  • Television receivers and video display monitors with cathode ray tubes only (21 CFR 1020.10)

  • Diagnostic x-ray systems and their major components (21 CFR 1020.30) (Includes medical x-ray, fluoroscopy)

  • Cabinet x-ray systems (21 CFR 1020.30) (Includes airport security x-ray system)

  • Microwave ovens (21 CFR 1030.10) (Includes consumer and commercial)

  • Laser products (21 CFR 1040.10) (Includes laser pointers, laser light shows, industrial laser, medical laser, surveying, leveling and alignment lasers)

  • Sunlamp products and ultraviolet lamps intended for use in sunlamp products (21 CFR 1040.20) (Includes tanning beds/booths)

  • High intensity mercury vapor discharge lamps (21 CFR 1040.30) (and metal halide lamps, for illumination)

  • Ultrasonic therapy products (21 CFR 1050.10) (for use in physical therapy)

Importers of radiation emitting-electronic products that are subject to performance standards must submit information on each product shipment to CBP and FDA. CBP’s regulation at 21 CFR 12.91 requires importers to affirm that products they are importing comply or do not comply with federal performance standards

FDA works with CPB by providing the Form FDA-2877, Declaration for Imported Electronic Products Subject to Radiation Control Standards. This form must be completed by the importer. Please see the back of the form for additional information/instructions.

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 that are not subject to federal performance standards.  Medical devices that are also radiation-emitting electronic products subject to federal performance standards will submit AofC codes as described in FDA’s March 24, 2011, letter along with the AofC codes listed in this letter.

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.

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. See below:

ELECTRONIC PRODUCT RADIATION CONTROL (EPRC) RELATED CODES:

  • EPRC Accession number (ACC) or EPRC Annual Report Number (ANC)

  • EPRC Model Number (MDL)

  • Affirmation code from Form FDA-2877

For more information on the specific product codes you can go to the following link: http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm271180.htm   or contact mdi at info@mdiconsultants.comRef: follow up to Import Entry Letter.