CSMS Message: 09-000315

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 or are of poor quality thus slowing the entry review process. Filers need to work closely with importers to ensure data quality. 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 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 provided at the time entry is also of importance. Filers should be aware that product codes can change for various reasons. Please verify with the importer that you are transmitting the appropriate product code for the product being imported.

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 side and the radiation emitting electronic product side.

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. 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

This code and qualifier 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

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.

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

This code and qualifier 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 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

This code and qualifier should be the manufacturer's model number or catalog number for the product identified in the FDA line.

PMA Device Premarket Approval Number

This code and qualifier 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))

This code and qualifier should be the device premarket notification (510(k)) number issued by CDRH for the product identified in the DFA 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 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 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 being returned to a U.S. resident. No qualifier is required but the quantity (number of units) must 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 of subassemblies to be used in manufacturing or as replacement parts (NOT APPLICABLE to diagnostic x-ray parts.) The qualifier required 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 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.

RB1 EPRC Product Declaration B1 (FDA 2877)

This code should be transmitted when compliance to 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 qualifier required 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 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.

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 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 AofC codes thirty days from issuance of this notification. 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 testing/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.

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 side and the radiation emitting product requirements, transmit AofC codes for both sides.

MEDICAL DEVICE AofC CODES

DEV or DFI
DII
LST
PMS 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 AND
MDL

NOTE: FDA will be posting an updated list of all current AofC codes on FDA's Internet site and to FDA's on-line Product Code Builder and Tutorial in the near future. A message to ABI filers will be issued once posted and will include the URL's to access.