Update on FDA's Letter for the Quick Release of Radiation-Emitting Electronic Products
A recent U.S. Customs and Border Protection CSMS message describes the importance of adhering to a September 6, 2011 Food and Drug Administration "Letter to Industry" on the entry of medical and non-medical radiation emitting electronic products. CBP states that the proper submission of the required entry information and the submission of voluntary Affirmation of Compliance (AofC) codes, will make it more likely that a shipment is processed based on import system screening and not held for further FDA entry review.
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(In March 2011, FDA issued a letter to the medical device industry about the number of imported medical devices that do not have sufficient entry information to allow FDA to make prompt admissibility decisions. FDA also issued a list of voluntary affirmations of compliance (AofC) for medical devices, and said it would be issuing a second letter on radiation-emitting medical and non-medical devices. See ITT’s Online Archives or 04/15/11 news, 11041501, for BP summary of FDA’s March 24, 2011 letter.)
Importers Must Work Closely with Brokers/Filers to Ensure Info is Correct
FDA stated in its September 6, 2011 letter that importers must work closely with their import personnel (brokers/filers) to verify that all required entry information is correct. 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, FDA encourages the submission of AofC codes along with their appropriate qualifier.
Products such as CRT TVs, Microwave Ovens, Laser Products, Etc. Need Form FDA-2877
According to FDA, importers of radiation emitting-electronic products that are subject to federal performance standards must submit information on each product shipment to CBP and FDA. CBP’s regulation at 19 CFR 12.91 requires importers to affirm that products they are importing comply or do not comply with federal performance standards. Form FDA-2877, Declaration for Imported Electronic Products Subject to Radiation Control Standards, is used for this purpose, and must be completed by the importer.
The products that are subject to federal performance standards include:
- Television receivers and video display monitors with cathode ray tubes (CRT) 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)
FDA states that the federal performance standards listed in 21 CFR 1010 and 1020 through 1050 are the applicable performance standards to which radiation-emitting electronic products must comply, versus any standards listed under recognized consensus or voluntary standards for medical devices.
In addition, 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. In these cases, Form FDA-2877 is not required.
AofC Codes that Should be Used to Expedite FDA Release Listed
The FDA's letter describes the AofC codes that can be provided at the time of entry to help expedite the admissibility process. 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.
FDA also states that to help expedite its 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 notice for AofC codes).
(See ITT's Online Archives or 09/09/11 news, 11090904, for BP announcement of the issuance of CBP's CSMS message.)
FDA's initial letter (dated 03/24/11) available here.
FDA's follow-up letter (dated 09/06/11) available here.
CSMS message #11-000211 available here