Medical Devices
Letter to Industry about Import Entry Review Process (September 6, 2011)
Dear Official Correspondent/United States Agent,
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.
Radiation-emitting electronic products are regulated by CDRH under sections 531-539 of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 360hh-360pp, as well as by regulations at 21 Code of Federal Regulations (CFR) Parts 1000 through 1050, and United States Customs and Border Protection (CBP) regulations (19 CFR 12.91). 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)
Please note 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.
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 (see http://edocket.access.gpo.gov/cfr_2005/aprqtr/pdf/19cfr12.91.pdf). 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. The Form FDA-2877 can be downloaded from this link:
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM080778.pdf
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.
In the following appendix, you will find AofC codes with their associated descriptions and qualifiers for radiation-emitting electronic products. 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:
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)
AND
ELECTRONIC PRODUCT RADIATION CONTROL (EPRC) RELATED CODES:
- EPRC Accession number (ACC) or
EPRC Annual Report Number (ANC) - EPRC Model Number (MDL)
AND, - Affirmation code from Form FDA-2877 (see appendix)
If you have any questions about the import entry review process for radiation-emitting electronic products or medical devices that are also radiation-emitting electronic products, or any general questions regarding the entry screening process, please contact the CDRH Office of Compliance Import/Export Safety Staff at cdrhocimport@fda.hhs.gov. In the email subject field, please specify “EPRC Inquires” so the email can be forwarded to the appropriate staff. If you have questions related to a specific detained entry, you must first contact the Import Compliance Officer in your local FDA District Office and reference the entry number for assistance.
Sincerely yours,
Helen Barr, MD
Director
Division of Mammography Quality and Radiation Programs
Office of Communication, Education and Radiation Programs
Center for Devices and Radiological HealthSteven Silverman
Director
Office of Compliance
Center for Devices and Radiological Health
Appendix – Radiation-Emitting Electronic Product Affirmation of Compliance (AofC) Codes
AofC codes, their titles, and descriptions are provided below. Use of these codes affirms that the product identified in a line meets the requirements specific to the code. While use of AofC codes is voluntary, transmission will help expedite the entry review process. Each code listed should only be used once per entry line.
CODE TITLE / DESCRIPTION
ACC EPRC Accession Number
This code and qualifier should be the Electronic Product Radiation Control (EPRC) Product report Accession Number issued by FDA identified in the FDA line.
Example ACC 102XXXX or ACC 101XXXX
ANC EPRC Annual Report Number
This code and qualifier should be the EPRC current annual report (due annually by September 1) accession number issued by CDRH for the product identified in the FDA line. The accession number should be current, no more than 2 years old.
Example ANC 103XXXX
MDL Model Number
This code and qualifier should be the manufacturer's Model Number or catalog number for the product identified in the FDA line.
Declaration A on Form FDA-2877
The following RA Codes are used when products are NOT SUBJECT TO RADIATION PERFORMANCE STANDARDS
RA1 EPRCProduct Declaration A1 (FDA-2877)
This code and qualifier should be transmitted for products that were manufactured prior to the effective date of an applicable performance standard. The qualifier needed is the date of manufacture.
RA2 EPRC Product Declaration A2 (FDA-2877)
This code and qualifier should be transmitted when the products are excluded from the applicability clause or definition in the standard or by FDA written guidance. Specific reason for exclusion is required with the transmission of this code.
For example, laser products which are purchased by Department of Defense (DOD) are allowed to be imported uncertified if they have met the DOD exemption requirements in 21 CFR 1010.50 and Laser Notice 52.
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm094416.htm
RA3 EPRC Product Declaration A3 (FDA-2877)
This code should be transmitted when the products are personal household goods of an individual entering the US, or being returned to a US resident. No qualifier is required but the quantity (number of units) must be transmitted at the FDA line level.
Examples include microwave ovens, laser optical drives inside CDs, DVD players, etc. Confirm personal household goods (limit = 3) and no distribution into US commerce.
RA4 EPRC Product Declaration A4 (FDA-2877)
This code should be transmitted when the products are property of a party residing outside the US and will be returned to the owner after repair or servicing.
For example, a Canadian firm is sending a non-certified commercial laser machine to U.S. for repair and will be returned to Canada.
RA5 EPRC Product Declaration A5 (FDA-2877)
This code and qualifier should be transmitted when the products are components or subassemblies to be used in manufacturing or as replacement parts (NOT APPLICABLE TO DIAGNOSTIC X-RAY COMPONENTS). The required qualifier is the textual description of the end product.
For example, laser diodes as component or replacement parts, by definition in 21 CFR 1040.10(a), don’t have to be certified upon entry.
RA6 EPRC Product Declaration A6 (FDA-2877)
This code should be transmitted when the products are prototypes intended for ongoing product development by the importing firm, are labeled “FOR TEST/EVALUATION ONLY”, and will be exported, destroyed, or held for future testing (i.e., not distributed). No qualifier is required but the quantity (number of units) must be transmitted at the FDA line level.
Quantities are limited per instructions on back of Form FDA-2877, for example TVs or Microwave Ovens = 50 units; Class 1 laser CD-ROM players or DVD players = 200 units. See May 14, 1997 notice in the following link:
RA7 EPRC Product Declaration A7 (FDA-2877)
This code and qualifier should be transmitted when the products are being reprocessed in accordance with P.L. 104-134 or other FDA guidance and are labeled “FOR EXPORT ONLY”, and will not be sold, distributed, or transferred without FDA approval. The qualifier required is the textual description of the end product.
For example, a US firm is importing uncertified laser product which is then installed inside medical equipment and then exported to a foreign buyer.
Declaration B on Form FDA-2877
The following RB Codes are used when products comply with Performance Standards. Select the code and qualifier, if appropriate, that best describes the product information being transmitted.
RB1 EPRC Product Declaration B1 (FDA-2877)
This code should be transmitted when compliance to the performance standards is documented in the most current annual report or product report. If this code is transmitted, the ACC or ANC code and qualifier must also be transmitted.
For example, RB1 ACC 101XXXX or RB1 ANC 103XXXX
RB2 EPRC Product Declaration B2 (FDA-2877)
This code and qualifier should be transmitted when the product complies with the standard but the manufacturer or product or annual report number is unknown. The qualifier required must state reason.
For example, the importer doesn’t know the name of the manufacturer or the accession number for the product report or annual report; however, importer can provide evidence such as photos of certification labels on the products that the products are in compliance with the US Federal performance standard. An example of when this code can be used would be when an importer purchased a large quantity of microwave ovens from a foreign distributor but was able to provide photographs of certification labels on the ovens (example, the certification label states “ This oven complies with U.S. Federal Performance Standard, 21 CFR 1030.10.”).
Declaration C on Form FDA-2877
The following RC Codes are used when products do not comply with performance standards; are being held under temporary import bond; will not be introduced into commerce; will be used under a radiation protection plan; and will be destroyed or exported under US Customs and Border Protection supervision when the following mission is complete. Select the code and qualifier, if appropriate, that best describes the product information being transmitted.
RC1 EPRC Product Declaration C1 (FDA-2877)
This code should be transmitted when the product does not comply and is imported for research, investigations, studies, or training. A Form FDA-766 will be required and must provide a full description of the subject electronic product, the purpose for which the product is being imported, how the product will be used, where the product will be located, and the approximate length of time and dates the product will be in the country. Entry cannot be released until the Form FDA-766 has been approved by the local FDA District Director.
RC2 EPRC Product Declaration C2 (FDA-2877)
This code and qualifier should be transmitted when the product does not comply and is for Trade Show/Demonstration use. The qualifier must list the dates of Trade shows and use restrictions, such as a sign stating that the product does not comply with FDA performance standards must be displayed at all times during use of products(s). All medical products, cabinet x-ray or Class IIIb and IV lasers may NOT operate (turn on products, at trade shows). (Form FDA-766 is not required).
Declaration D on Form FDA-2877
The following RD Codes are used when products do not comply with Performance Standards; are being held and will remain under bond; will not be introduced into commerce until notification is received from FDA that the products have been brought into compliance in accordance with an FDA approved petition. A Form FDA-766 will need to be supplied to bring these products into compliance. Select the code and qualifier, if appropriate, that best describes the product information being transmitted. Note: the process of “reconditioning” non-compliant radiation emitting electronic products may be difficult, time consuming and the importer may be at risk of losing money as well as the products, if the reconditioning is unsuccessful. The importer should make a serious effort to understand the FDA radiation safety requirements that are applicable to the products being imported.
RD1 EPRC Product Declaration D1 (FDA-2877)
This code should be transmitted when products do not comply with the applicable performance standard and an approved petition (Form FDA-766) is provided.
RD2 EPRC Product Declaration D2 (FDA-2877)
This code should be transmitted when products do not comply with the applicable performance standard and a detailed petition (Form FDA-766) request is provided for FDA approval.
RD3 EPRC Product Declaration D3 (FDA-2877)
This code should be transmitted when products do not comply with the applicable performance standard. A detailed petition (Form FDA-766) request will be provided within 60 days for FDA approval.
