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Affirmation of Compliance (AofC)

Exporters need an outline of the kind of information needed for the U.S. Food and Drug Administration (FDA) to make prompt admissibility decisions on products arriving at designated ports of entry. Use of the appropriate Affirmation of Compliance (AofC) codes and qualifiers will expedite the admissibility process for Exporters.

When a product arrives at a US port of entry, certain information must be provided/transmitted electronically to the United States Customs and Border Protection (CBP). If the product is or may be regulated by FDA, CBP sends the import entry information to FDA for verification to ensure that the product meets FDA requirements. While use of these AofC codes is voluntary, transmission will help expedite the entry review process and increase the likelihood that the shipment may be processed based on import system screening.

The FDA has developed new AofC codes and revised old AofC codes appropriate for use when transmitting entries of imported products. The following is a list of several AofC codes with their associated descriptions and qualifiers.

FOOD

AIN: Food Additive Identification Number
This affirmation is used only when importing the pure food additive intended for use in a food manufacturing process and the qualifier can be:
The CAS (Chemical Abstract System) number. (The format of a CAS Number is typically: 10-00-0)
The FEMA (Food Extract Manufacturing Association) number used to identify flavor extracts used as food additives. (The format of a FEMA Number is typically: 1000)
The European Economic Community has identified food additives by “E” numbers. (The format of an E Number is typically: E100)
Example: AIN 59-47-9, AIN 10192-71-3

FAP: Food Additive Petition Approval Number
This affirmation is used only when importing the pure food additive which will be used in a food manufacturing process. This affirmation and qualifier should be the Food Additive Petition Approval Number issued by FDA/CFSAN for the product identified in the FDA line.
Example: FAP 123456.

FCC: French Cheese Facility Certification Number
This affirmation and qualifier should be the French Cheese Facility Certification Number issued by the French government for the product/plant identified in the FDA line.
Example: FCC 7906101.

FCE: Food Canning Establishment Number
This affirmation and qualifier should be the Food Canning Establishment Number (FCE) that identifies a manufacturer of acidified and/or low-acid canned food products. The qualifier should be the Food Canning Establishment Number issued by FDA where the site specific manufacturer of Low Acid and/or Acidified Food is registered. Form FDA 2541 is used for the manufacturing firm registration. When possible, the Affirmation of Compliance Codes for the SID (Submission Identifier), VOL (Volume) and/or specific container size/dimensions should also be used when the FCE affirmation code is provided.
Example: FCE 12345.

IBP: Indian Black Pepper Certificate
This affirmation and qualifier should be used when the manufacturer has provided an Inspection Certificate for Export of Black Pepper from the Export Inspection Agency, Ministry of Commerce, Government of India, which includes results of filth and salmonella analyses. The qualifier should be the Certificate number.
Example: IBP A19508, IBP BP/C- 09924.

RF1 – RF5: Imported Foods Refused Entry by Another Country (FSMA Section 304 Requirement)
These affirmation codes and qualifiers should be used to report the name(s) of up to five (5) countries or areas where the article of food, including food for animals, has been refused entry. This information is required by Section 304 of the Food Safety Modernization Act (FSMF) of January, 2011. Commodities other than food that have been refused entry by another country should be transmitted with the UFC (Unacceptable to Foreign Country) affirmation.
Example: RF1 France, RF2 Japan.

SID: Submission Identifier (SID) Number
This affirmation and qualifier should be the number identifying a specific process filing for a Low Acid or Acidified Food Product filed with FDA for the product identified in the FDA line. When using the SID code, the FCE code and qualifier, along with the container size/dimensions and/or VOL with qualifier must also be transmitted. The filer should verify with the manufacturer whether container size/dimensions or volume were supplied to FDA for the SID identified. Container size/dimensions must be entered as described in the Transmission of Data portion of this document. The format of the SID data may be dependent on your vendor’s specific software implementation, but, would include the year, month, day and ID of the product.
Example: 2011-06-23/005, 20110623005.

SIF: Seafood HACCP Importer Firm
This AofC code and required qualifier should be used to identify the responsible U.S. firm as defined by 21 CFR 123.3. The HACCP Importer is defined as either the U.S. owner or the U.S. consignee at the time of entry, responsible for ensuring the goods are in compliance with the requirements of the HACCP regulation. The term HACCP “Importer” is not the same as the “Importer of Record” as defined by U.S. Customs regulations. However an Importer of Record may also be the U.S. owner or U.S. consignee.The qualifier required is the FDA Establishment Identifier (FEI) for the HACCP Importer. If not already known, filers can do an ABI query for the firm’s FEI for use in transmission of this AofC code.
Example: SIF 003888440551.

VOL: LACF/ AF Volume (Low Acid Canned Food / Acidified Food)
This affirmation and qualifier can be used to communicate the container volume and unit of measure of an Acidified Food (AF) or Low-Acid Food product that is packaged in a container that does not have a traditional size/dimension. The filer should verify with the manufacturer whether container size/dimensions or volume were supplied to FDA for the SID identified. The VOL code is acceptable for glass or ceramic containers and semirigid container, large steel or plastic drums, pails, fiberboard, large industrial sized containers.
Example: VOL 16 oz, Container Size/Dimension is a fielded data elements described below in the “Transmission of Data Guidance” section.

PND: Prior Notice Disclaim (No qualifier required)
This affirmation is used when the tariff code is flagged as FD3 but the product is not subject to Prior Notice. The PND code is used to indicate that the product is not subject to Prior Notice, otherwise the system would expect to see PN data. Use of PND doesn’t preclude the use of other AofC codes like IND.
Example: PND

FOOD CONTACT SUBSTANCES

CCC: Chinese Ceramicware Factory Code
This affirmation and qualifier should be used to indicate shipments of ceramicware are produced by a manufacturer certified as part of a FDA/Peoples Republic of China (PROC) Memorandum of Understanding (MOU). The code requires a qualifier consisting of the factory code assigned to the individual manufacturer. This code will have to be obtained from the manufacturer by the filer or their client. Paper certificates (CCIB) will no longer be used in FDA’s evaluation of these entries. The qualifier is the factory code assigned to the individual manufacturer.
Example: CCC 13X005.

CIN: Color Index Number
This affirmation and qualifier is only used when importing the pure color additive to be used in FDA regulated items. The affirmation and qualifier should be the Color Identification Number recognized as the international color identification number for the product identified in the FDA line.
Example: CIN RED 40 /BLUE 1.

COSMETICS

COS: Cosmetic Registration Number
This affirmation and qualifier should be the Cosmetic Registration Number issued by FDA/CFSAN for the firm manufacturing the product identified in the FDA line. Form FDA 2511 should be used for registration. This is a voluntary registration. The assignment of a registration number by FDA does not denote approval of a firm, raw material, or product by FDA.
Example: F1061499.

MEDICAL DEVICES

CPT: Device Component (No qualifier required)
This affirmation and qualifier should be used when importing a component of a device that requires further processing or inclusion into the finished device. Component means any raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of the finished, packaged, and labeled device. Finished device means any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized. This code is not to be used if the device component is classified by FDA as a finished device.

DDM: Domestic Device Manufacturer
This affirmation and qualifier should be the device registration number or owner operator number issued by FDA/CDRH for the U.S. firm manufacturing the product identified in the FDA line. DDM is only to be used for those U.S. manufactured devices declared as part of a kit.

(Note: The DDM should always be associated with the U.S. manufacturer and not the Foreign Manufacturer)

Example: DDM 3003999999.

DEV: Device Foreign Manufacturer Registration Number
This affirmation and the qualifier for this code should be the device registration number or owner operator number issued by FDA/CDRH for the firm manufacturing the product identified in the FDA line.

(Note: The DEV should always be associated with the foreign manufacturer and not the US specifications developer)

Example: DEV 3003999999, DEV 9699123.

DFE: Device Foreign Exporter Registration Number
This affirmation and the qualifier for this code should be the device registration number or owner operator number issued by FDA/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.
Example: DFE 3003999999, DFE 9710083.

DII: Device Initial Importer Registration Number
This affirmation and the qualifier for this code should be the device registration number issued by FDA/CDRH for the importer who takes first title to devices imported into the U.S.
Example: DII 3003999999

HDE: Humanitarian Device ExemptionAn Humanitarian Use Device (HUD) is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year. To obtain approval for an HUD, an humanitarian device exemption (HDE) application is submitted to FDA.

IDE: Investigational Device Exemption Number
This affirmation and qualifier should be the Investigational Device Exemption Number issued by FDA/CDRH for the product identified in the FDA line. Devices that qualified experts use on human subjects, to conduct investigations of their safety and effectiveness, are considered investigational devices. The qualifier for this code should be the investigational device exemption number issued by FDA/CDRH for the product identified in the FDA line.
Example: IDE G089911.

IRC: Impact Resistance Lens Certification (No qualifier required)
This affirmation 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. Note: FDA has the authority to ask for copies of the actual test results. Each shipment must have its own test results unless it is part of a larger lot that was shipped to the U.S. over time.
Example: IRC.

KIT: Imported Kit of Finished Devices (No qualifier required)
This affirmation should be used for all individual devices within kits imported in the US. Additionally, some kits contain drug products which must comply with applicable labeling and approval requirements including but not limited to application number, registration, and listing. Kit importers should consider obtaining the Affirmation of Compliance information from their vendors to minimize the need for manual review of applicable lines by the FDA.
Example: KIT.

LST: Device Listing Number
This affirmation and the qualifier for this code should be the device listing number issued by CDRH for the product identified in the FDA Line.
Example: LST E199100.

LWC: (Electrode) Lead Wire or Patient Cable (No qualifier required)
This affirmation should be used when importing electrode lead wires, patient cables, or devices that use them. The affirmation indicates either (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 affirmation and qualifier should be the manufacturer’s model number for the product identified in the FDA line. There is no specific format for this qualifier. The model data may be whatever the manufacturer uses as a model number.
Example: MDL AAA-1234, MDL X98-0345673, MDL 65-125.

PDP: Product Development Protocol Number
The product development protocol (PDP) method for gaining marketing approval allows a sponsor to come to early agreement with FDA as to what would be done to demonstrate the safety and effectiveness of a new device.

PMA: Device Premarket Approval Number
This affirmation and 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.
Example: PMA P979999 Premarket Approval, PMA D970000 Product Development Protocols, PMA H970000 Humanitarian Device Exemption, PMA N000000 Valid Grandfathered Prefix.

PMN: Device Premarket Notification Number (510k)
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. PMN number should always be the number that is on the listing record.
Example: PMN K979009.

DRUGS

AND: Abbreviated New Drug Application Number
This affirmation and qualifier is the Abbreviated New Drug Application Number (ANDA) issued by FDA, Center for Drug Evaluation and Research (CDER), for the generic human drug product identified in the FDA line. The qualifier is six digits. If less than six digits, preceding zeros may be used to make six digits.
Example: AND 004444.

DLS: Drug Listing Number
This affirmation and qualifier should be the Drug Listing Number issued by FDA/CDER for the BULK drug product identified in the FDA line. The drug listing number is provided on the application for drug listing, Form FDA 2657. All foreign drug establishments shall comply with the drug listing requirements. Bulk drug substances are identified and reported using a unique, three-segment number. The DLS affirmation is *not* used for finished drug products.
Example: DLS 4444-333-22, DLS 4444-4444-22, DLS 55555-333-22, DLS 55555-4444-1.

IND: Investigational New Drug Number
This affirmation and qualifier is the Investigational New Drug Number (IND) issued by FDA/CDER for the product identified in the FDA entry line. Investigational drugs are new drugs intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of drugs. The FFD&C Act requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines (including import). A sponsor, who wants to ship the investigational drug to clinical investigators, must seek an exemption from that legal requirement. The IND is the means through which the sponsor obtains its exemption from the FDA. An active IND allows for the shipment of an investigational new drug.
Example: IND 999000, IND 055555.

NDA: New Drug Application Number
This affirmation and qualifier is the New Drug Application Number issued by FDA/CDER for the product identified in the FDA line. A new drug cannot be commercially marketed in the U.S. unless it has been approved as safe and effective by the FDA based on a New Drug Application. The qualifier required is the NDA number assigned to the product by FDA. If less than six (6) digits are given, then zeros precede the number to make 6 digits in total.
Example: NDA 055555.

NDC: National Drug Code
This affirmation and qualifier is the National Drug Code listed with FDA/CDER for the finished dosage form drug product identified in the FDA line. The NDC Directory contains ONLY information on final marketed drugs submitted to FDA in electronic listing files by labelers. Inclusion of information in the NDC Directory does not indicate that FDA has verified the information provided. Assignment of an NDC number does not denote FDA approval of the product. Any representation that creates an impression of official approval because of possession of an NDC number is misleading and constitutes misbranding (21 CFR 207.39). The qualifier required is the NDC number assigned to the product by FDA/CDER.
Example: NDC 4444-333-22, NDC 4444-4444-22, NDC 55555-333-22

REG: Drug Registration Number
This affirmation and qualifier is the Drug Registration Number issued by FDA/CDER for the firm manufacturing the product identified in the FDA line. The Federal Food, Drug and Cosmetic Act (FFD&CA) Section 510[21 USC 360] requires most establishments that manufacturer, prepare, propagate, compound, or process a drug or drugs, to register with the FDA. A firm Registration Number is presented to the establishment upon registering with FDA/CDER. Currently, the establishment registration number is the Dunn and Bradstreet number (DUNS).
Example: REG 999999999.

VAN: VeterinaryAbbreviated New Animal Drug Number
This affirmation and qualifier should be the Veterinary Abbreviated New Animal Drug Number (VAN) issued by FDA, Center for Veterinary Medicine (CVM), for the animal drug product identified in the FDA line. This number is the approval number for an abbreviated new animal drug application. Animal drugs have to be shown to be generally safe and effective for each use in each animal species for which they are intended. In addition to the general requirements for efficacy and safety for animal use, animal drugs intended for use in food producing animals must not leave unsafe residues in edible tissues or other food products for human consumption.

This application is used when a sponsor is pursuing approval of a generic drug. It is “abbreviated” because certain requirements of 21 CFR 514 can be met by referencing an approved VNA (Veterinary New Animal Drug Application Number) for which the patent protection or a period of exclusivity has expired.
Example: VAN 299-1234 (six digit number) The qualifier begins with a “2.”

VFL: Veterinary Feed Mill License
This affirmation and qualifier should be the Veterinary Medicated Fee Mill License number assigned by FDA/Center for Veterinarian Medicine (CVM) for animal feeds containing new animal drugs. The qualifier is the FDA license number assigned by FDA/CVM.
Example: VFL 500-000 (six digit number) the qualifier begins with a “5.”

VIN: VeterinaryInvestigational New Animal Drug Number
This affirmation and qualifier should be the Veterinary Investigational New Animal Drug Number issued by FDA/CVM for the product identified in the FDA line. Investigational new animal drugs are animal drugs that may be distributed solely for investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of animal drugs for a particular purpose. An unapproved new animal drug (distributed in accordance with 21 CFR Part 511) can be used for research for the collection of data intended to be submitted in support of an VNA (Veterinary New Animal Drug Application Number) approval; or a generic VIN (Veterinary Investigational New Animal Drug Number).
Example: VIN 12-345.

VMS: Veterinary Minor Species Index File
This affirmation and qualifier should be used for the product identified in the entry line when the intended use of the drug in a minor species, for an indication that occurs infrequently and in only a small number of animals or in limited geographical areas and in only a small number of animals annually.
Example: VMS 123-456 (six digit number)

VNA: Veterinary New Animal Drug Application Number
When the sponsors believe that sufficient data have been collected to establish the safety and effectiveness of their drug product, they may apply for approval. A New Animal Drug Application (NADA) is submitted along with supporting data, including all adverse effects associated with the drug’s use. The NADA must also include information on the drug’s chemistry; composition and component ingredients; manufacturing methods, facilities, and controls; proposed labeling; analytical methods for residue detection and analysis if applicable; an environmental assessment; and other information.
Example: VNA 123-456 (six digit number), VNA 1-234 (approval prior to 1990 may have four digits x-xx.

BIOLOGICS

AND: Biologics (CBER) Abbreviated New Drug Application Number
This affirmation and qualifier should be the Abbreviated New Drug Application Number (AND) issued by FDA/CBER for the generic human drug product identified in the FDA line. This number is the approval number in response to an abbreviated new drug application by FDA/CBER and it begins with ‘BA’ followed by numbers.
Example: AND BA1234, AND BA12345.

BLN: Biologics License Number
This affirmation and the qualifier for this code should be the four digits of the U.S. Biologics License Number issued by FDA, Center for Biologics Evaluation and Research to the manufacturer of the biological product identified in the FDA line. The Biologics License Number is the U.S. license number (not the Submission Tracking Number (STN)). The BLN at a maximum would be a four digit number.
Example: BLN 1234.

STN: Biologics Submission Tracking Number
This affirmation and the qualifier for this code should be the Submission Tracking Number issued by FDA’s Center for Biologics Evaluation and Research for the licensed biological product identified in the FDA line. The Submission Tracking number is the biologics license application (BLA) number. The STN is associated with the manufacturer and a specific product. The first six digits represent the original submission tracking number.
Example: STN 123456.

HCT: Human Cells, Tissues and Cellular and Tissue-based Products. (No qualifier required)
This affirmation should be used to indicate the HCT/P being imported or offered for import is in compliance with all applicable requirements of 21 CFR 1271.
Example: HCT

HRN: Human Cells, Tissues and Cellular and Tissue-Based Product Establishment Registration Number
This affirmation and qualifier is used if the establishment is registered with the FDA. The required qualifier should be the HCT/P establishment registration number issued by FDA’s Center for Biologics Evaluation and Research (CBER) for the product’s manufacturing firm identified in the FDA entry line. Most foreign manufacturers of biologic products are required to register and submit a list of every HCT/P manufactured (21 CFR 1271.21), except those exempt from registration under 21 CFR 1271.15. For Example; individuals (such as physicians) are not required to register or list if they are under contract, agreement, or other arrangements with a registered establishment and engaged solely in recovering tissue.

Preceding zeros are used to assure the qualifier is always 10 characters.
Example: HRN 0001234567, HRN 1234567890

RADIATION-EMITTING PRODUCTS

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.
Example: ACC 1210000

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.
Example: ANC 123xxxx (no more than two years old)

CCM: Electronic Product Radiation Control (EPRC) Certifying Component Manufacturer
This affirmation and qualifier should be used to name the certifying component manufacturer (CCM) of the certified Electronic Product Radiation Control (EPRC) component incorporated in the finished product being imported. The name of the CCM manufacturer must be the one that appears in the referenced product (ACC) and/or annual report (ANC) affirmations. This affirmation is only used when the name of the manufacturer of the finished product is different that the name of the certifying component manufacturer.

MDL: Model Number
This affirmation and qualifier should be the manufacturer’s model number for the product identified in the FDA line. There is no specific format for this qualifier. The model data may be whatever the manufacturer uses as a model number.
Examples: MDL AAA-1234, MDL X98-0345673, MDL 65-125

RA1: EPRC Product Declaration A1
This affirmation and qualifier should be transmitted for products that were manufactured prior to the effective date of an applicable performance standard. The qualifier is the date of manufacture, which must be the date before the performance standard was effective.
Example: RA1 Feb 5, 2011

RA2: EPRC Product Declaration A2
This affirmation 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, as the qualifier, with transmission of this code.
Example: RA2 Laser Notice 52- DOD Exemption

RA3: EPRC Product Declaration A3 (No qualifier required)
This affirmation 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 is limited to 3 of each product and it 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). No introduction into U.S. commerce is permitted.
Example: RA3

RA4: EPRC Product Declaration A4 (No qualifier required)
This affirmation 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. No qualifier is required, however firm must document import/export process. No introduction into U.S. commerce is permitted.
Example: RA4

RA5: EPRC Product Declaration A5
This affirmation 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 qualifier required is the textual description of the end product.
Example: RA5 Laser diodes

RA6: EPRC Product Declaration A6 (No qualifier required)
This affirmation should be transmitted for specified radiation emitting electronic products(Class 1 optical drives, microwave ovens, and TV receiver (CRT only) and intended for ongoing product development by the importing firm. The products 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 2877.
Example: RA6

RA7: EPRC Product Declaration A7
This affirmation 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,” after reprocessing. Products being reprocessed must be exported by the importer, without intermediate transfer of ownership. The qualifier required is the textual description of the end product.
Example: RA7 Laser medical device for Europe market; outside containers are marked “FOR EXPORT ONLY”

RB1: EPRC Product Declaration B1
This affirmation and qualifier should be transmitted when compliance to the performance standard is documented in the most current annual report (code is ANC) or Product/Initial/ Abbreviated report (code is ACC). If this code is transmitted, the ACC or ANC code and qualifier must also be transmitted. The Manufacturer’s name in either report must match the name on the Form FDA 2877.
Examples: RB1 and ACC 1114999 OR ANC 1135999

RB2: EPRC Product Declaration B2
This affirmation and qualifier should be transmitted when the product complies with the standard but the manufacturer or report numbers are unknown. The qualifier required must state reason the product complies.
Example: RB2 Filer submitted digital photos of cert labels affixed to the products.

RC1: EPRC Product Declaration C1
This affirmation should be transmitted when the product does not comply and is for research, Investigations/Studies, or training. 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.
Example: RC1 (attach form FDA766 and evidence of TIB)

RC2: EPRC Product Declaration C2
This affirmation and qualifier should be transmitted when the product does not comply with the applicable performance standard and is being imported for trade shows or demonstrations. The qualifier must list the dates of trade shows. Use restrictions, such as a sign stating that “The product does not comply with FDA performance standards” must be displayed at all times during the display of the products(s). All medical products, cabinet x-ray or Class IIIb and IV lasers may NOT be powered on at tradeshows. It is recommended that these devices be disabled in such a way as to not be accidently powered on. Non-compliant signs must be posted on products while at the show. Form FDA766 is not required. Importer must obtain Temporary Import Bond (TIB).
Example: RC2 Trade show June 2-6, 2012; TIB is attached

RD1: EPRC Product Declaration D1 (No qualifier required)
This affirmation should be transmitted when products do not comply with the applicable U.S. Federal Performance Standard and an approved petition (Form FDA 766) is provided. Entry must be held intact in bonded warehouse and an approved Form FDA 766 must be provided along with TIB, approved CAP, and a radiation safety product report accepted by CDRH.
Example: RD1 (and attach an approved form FDA 766 along with evidence of Temporary Import Bond (TIB))

RD2: EPRC Product Declaration D2 (No qualifier required)
This affirmation should be transmitted when products do not comply with the applicable U.S. Federal Performance Standard and a petition request (Form FDA 766) is provided for approval. Entry must be held intact in bonded warehouse; obtain Form FDA 766, and Temporary Import Bond (TIB). The firm’s CAP and radiation safety product report are to be reviewed by Import Office and CDRH. The reconditioning cannot proceed without an approved Form FDA 766.
Example: RD2

RD3: EPRC Product Declaration D3
This affirmation should be transmitted when products do not comply with the applicable U.S. Federal Performance Standard and a detailed petition (Form FDA 766) will be provided within 60 days for FDA approval. Entry must be held intact in bonded warehouse, and the entry must be placed on Temporary Import Bond (TIB). The importer has 60 days to submit Form FDA 766 and provide the CAP and radiation safety product report (which will be jointly reviewed by the District Office and CDRH).
Example: RD3 “Petition Form FDA 766 will be provided within 60 days; TIB is obtained for the entry.”

MISCELLANEOUS

ERR: Entry Review Recommended
This affirmation, with a required qualifier, can be used when a filer becomes aware, prior to transmitting entry data, there is a legitimate need for FDA to examine the commodities in an entry e.g., the filer has been notified that refrigeration failure in a truck or ship has caused damage to a partial or total shipment. Transmission of this code will generate a “Hold Line” on screening and eliminate the need to return a shipment for FDA sampling. This code can also be used, at FDA’s request, if a filer is asked to withdraw and retransmit an entry to correct an erroneous “May Proceed”. The qualifier (up to 20 characters) should indicate the reason the code is being transmitted.
Example: ERR damaged in shipment

IFE: Import for Export (No qualifier required)
This affirmation allows for importation of violative articles or non-compliant articles (including drug and device components, food and color additives, and dietary supplements) under the new import for export provisions of the FD&C Act [801(d)(3)(a)]. The imported article must be incorporated, by the initial owner or consignee, (which can be someone other than the importer of record) into a product for export. The product must be exported from the United States by this initial owner or consignee in accordance with the provisions of Section 801(e) and 802 of the FD&C Act or 351(h) of the PHS Act. This affirmation cannot be used for transshipment of devices through the United States. It cannot be used to store, in U.S. warehouses, finished devices intended solely for import. No qualifier is required but QUANTITY AND VALUE MUST BE TRANSMITTED when using this AofC.

UFC: Unacceptable to Foreign Country
This affirmation, with a required qualifier, can be used when a filer becomes aware, prior to transmitting entry data, that a shipment or portion of a shipment of NON-FOOD products has been rejected by another country’s government agency. FDA may be notified of this reject for appropriate action. Transmission of this code will generate a “Hold Line” on screening and eliminate the need to return a shipment for FDA sampling. This code can also be used, at FDA’s request, if a filer is asked to withdraw and retransmit an entry due to FDA receipt of such a reject report. The required qualifier should include the identification of the foreign country’s reject report (up to 25 characters). Imported food products (including animal foods) that have been refused by other countries should be reported using the Food Safety Moderation Act 2011 (FSMA) Affirmation of Compliance code RF1 through RF5. The RFx codes allow for the names of up to 5 different countries that have refused the food product identified in the transmitted entry line.
Example: UFC “unacceptable steel standards”





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