| Title: | FDA Filer Outreach on ITACS/PREDICT/AofC Codes |
|---|---|
| Date: | 2009-10-09 |
| To: | abi |
| Links: | previous, next |
FDA Filer Outreach on ITACS/PREDICT/AofC Codes
September 24, 2009
FDA's Center for Devices and Radiological Health
Affirmation of Compliance Codes
The Food and Drug Administration (FDA) will be launching a new automated import admissibility screening module, PREDICT, which requires accurate Affirmation of Compliance (AofC) codes in order to expedite the entry review process. Based on simulation testing of PREDICT, AofC codes are either missing, provided in the wrong data transmission fields, or are of poor quality thus slowing the entry review process. As such, it is imperative that filers work closely with their importers to ensure complete and accurate data. When PREDICT comes online, the quality of the data transmitted will greatly affect both the automated and manual aspects of the entry review process. Many of the AofC codes transmitted will be used to perform automated database look-ups of FDA Center databases to determine if admissibility requirements such as registration, listing and premarket approval have been met.
Please note: The product code(s) provided at the time of entry are also very important. Filers should be aware that product codes can change for various reasons. Please verify with the importer that the appropriate product code is being transmitting for the product being offered for import.
The FDA's Center for Devices and Radiological Health (CDRH) has developed new AofC codes and revised old AofC codes appropriate for use when transmitting entries of imported medical devices and radiation emitting electronic products subject to a performance standard under Title 21 Code of Federal Regulations (CFR) Subchapter J. NOTE: For medical devices that are also radiation emitting electronic products, filers should transmit AofC codes for both the medical device requirements and the radiation emitting electronic product requirements.
Radiation emitting electronic products that are subject to a performance standard require the submission of a “Declaration for Imported Electronic Products Subject to Radiation Control Standards” form FDA 2877. When electronically filing this data, please refer to the actual form for an explanation of the declaration being transmitted.
The AofC codes, their titles, and descriptions are provided below for your reference. Use of these codes affirms that the product identified in a FDA line meets the requirements specific to the code. While use of these codes is voluntary, transmission will help expedite the entry review process.
CODE TITLE/DESCRIPTION
ACC EPRC Accession Number
The qualifier for this code should be the Electronic Product Radiation Control (EPRC) product or abbreviated report accession number issued by CDRH for the product identified in the FDA line.
ANC EPRC Annual Report Accession Number
The qualifier for this code 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.
CPT Device Component
This code should be used when importing a component of a device that requires further processing or inclusion into the finished device. This code is not to be used if the device component is classified by FDA as a finished device, e.g., wheelchair component.
DEV Device Foreign Manufacturer Registration Number
The qualifier for this code should be the device registration number issued by CDRH for the firm manufacturing the product identified in the FDA line.
DFE Device Foreign Exporter Registration Number
The qualifier for this code should be the device registration number issued by CDRH for the exporter who exports or offers for export to the United States (U.S.), a device manufactured or processed by another individual, partnership, corporation or association in a foreign country, as well as devices originally manufactured in the United States.
DII Device Initial Importer Registration Number
The qualifier for this code should be the device registration number issued by CDRH for the importer who takes first title to devices imported into the U.S.
IDE Investigational Device Exemption Number
The qualifier for this code should be the investigational device exemption number issued by CDRH for the product identified in the FDA line.
IRC Impact Resistance Lens Certification
This code is used to certify that the filer has on hand the test results or a certificate that shows that the product on the FDA line has met the standards for impact resistance lens.
LST Device Listing Number
The qualifier for this code should be the device listing number issued by CDRH for the product identified in the FDA Line.
LWC (Electrode) Lead Wire or Patient Cable
This code should be is used when importing electrode lead wires, patient cables, or devices that use them. The affirmation means that (1) the device shipment does not contain any pre-wired electrodes, electrode lead wires, or patient (transducer) cables, or (2) any pre-wired electrodes, electrode lead wires or patient cables comply with 21 CFR 898, Performance Standard for Electrode Lead Wires and Patient Cables.
MDL Model Number
The qualifier for this code should be the manufacturer's model number or catalog number for the product identified in the FDA line.
PMA Device Premarket Approval Number
The qualifier for this code should be the device Premarket Approval (PMA) number, product development protocols (PDP) number or Humanitarian Device Exemption (HDE) number issued by CDRH for the product identified in the FDA line.
PMN Device Premarket Notification Number (510(k))
The qualifier for this code should be the device premarket notification (510(k)) number issued by CDRH for the product identified in the FDA line.
Electronic Product Radiation Control (EPRC) Codes:
RA1 EPRC Product 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 required qualifier 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(s) for exclusion is required with transmission of this code.
RA3 EPRC Product Declaration A3 (FDA 2877)
This code should be transmitted when the products are personal household goods of an individual entering the U.S. or returning as a U.S. resident. No qualifier is required but the quantity (number of units) should be transmitted at the FDA line level.
RA4 EPRC Product Declaration A4 (FDA 2877)
This code should be transmitted when the products are property of a party residing outside the U.S. and will be returned to the owner after repair or servicing.
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 parts.) The required qualifier is the textual description of the end product.
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.
RA7 EPRC Product Declaration A7 (FDA 2877)
This code and qualifier should be transmitted when the products are being reprocessed in accordance with The FDA Export Reform and Enhancement Act of 1996 (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 required qualifier is a textual description of the end product.
RB1 EPRC Product Declaration B1 (FDA 2877)
This code should be transmitted when compliance with the performance standard is documented in the most current annual report or Product/Initial report. If this code is transmitted, the ACC or ANC code and qualifier must also be transmitted.
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 report number are unknown. The required qualifier must state reason.
RC1 EPRC Product Declaration C1 (FDA 2877)
This code should be transmitted when the product does not comply and is for research, Investigations/Studies, or Training. A FDA Form 766 shall 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.
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 only. The qualifier must list the dates of the 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 product(s). All medical products, cabinet x-ray or Class IIIb and IV lasers may NOT operate (turn on products, at trade shows). A Form FDA 766 shall be required.
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.
NOTE: FDA will be end-dating four (4) AofC codes thirty (30) days following issuance a notification via CBP's Cargo Systems Messaging Service (CSMS). The codes to be end-dated are:
RAA Product is not subject to performance standard.
RAB Product complies with applicable performance standard.
RAC Product does not comply with performance standard. Imported under a temporary import bond. Product is for esting/evaluation/training/demonstration.
RAD Product does not comply with performance standard but will be brought into compliance under an approved corrective action plan. Imported under a temporary import bond.
In addition the following product 25 codes will be end dated at the same time.
94A--11 Accelerator for Non-medical Use
94C--08 Cold-Cathode Gas Discharge Tube for Non-medical Use
94H--04 High Voltage Vacuum Tube
94H--06 High Voltage Vacuum Switch
94I--13 Industrial X-Ray System (Except Cabinet)
94I--17 Cabinet X-Ray System
94N--14 Analytical X-Ray System or Component for Non-medical Use
94V--01 Boards, Printed Circuit
94V--02 Circuit Breaker, Automatic
94V--05 Cathode Ray Tube
94V--07 TV Receiver or Product Cont. TV Receiver, Television, Computer Monitor
95L--22 Laser Product for Non-Medical Use
95L--29 Laser Light Show
95L--30 Laser Printers
95L--31 CD Players (compact disc players)
95L--32 CD Player Combination Systems
95U--19 Sunlamp Product (Pre-standard) for Non-medical Use
95U--20 Ultraviolet Product (Miscellaneous) for Non-medical Use
95U--28 Mercury Vapor Lamp for Non-medical Use
96H--02 Microwave Heating Product (Except Oven for Food Preparation) for Non-medical Use
96H--27 Industrial Dielectric Heater
96M--01 Microwave Oven for Food Preparation
97U--09 Ultrasound Product for Non-medical Use
97Y--35 Sound Product (other than Ultrasound) for Non-medical Use
97Y--36 Cordless Phones
Listed below are examples of AofC codes that should be transmitted at the time of entry for a medical device and a radiation emitting product subject to a performance standard. For products subject to both the medical device requirements and the radiation emitting product requirements, transmit AofC codes for both.
MEDICAL DEVICES AofC Codes
DEV or DFE
DII
LST
PMA or PMN or HDE or PDP or IDE
MDL
RADIATION EMITTING PERFORMANCE STANDARD AofC Codes
RA1 or RA2 or RA3 or RA4 or RA5 or RA6 or RA7
RB1 or RB2
RC1 or RC2
RD1 or RD2 or RD3
ACC or ANC
MDL
Transmission of Data
NOTE: Affirmation of Compliance information should not be transmitted in any other field than those described below. The Importer's description should be reserved for use in describing the product being offered for import.
Affirmation of Compliance
A single Affirmation of Compliance (AofC) code with or without qualifier is input on the FD01 Record. Any additional AofC codes (2nd up to 999), with or without qualifiers, can be furnished using the FD05 Record. The Affirmation of Compliance Code is a three-character field. If an Affirmation of Compliance Qualifier is required, this field is a 25-character field and must be used. Be sure to follow your software vendor's instructions.
Quantity
Quantity and Units of Measure Pairs (FD02 & FD04 RECORDS). Multiple positions are used as needed to describe the quantity. Two decimal places are implied. If the value is a whole number, the two low-order positions contain zeros. Consult the FDA ACS Interface Quantity Data Instructions for further information. Be sure to follow your software vendor's instructions.
NOTE: FDA will be posting an updated list of all current AofC codes on FDA's Internet site and in FDA's on-line Product Code Builder Tutorial. A message to ABI filers will be issued once posted and will include the URL's to access.