The FDA recently issued a Letter to Industry with recommendations for using Affirmation of Compliance (AofC) codes to expedite release of goods from US Customs and Border Protection (CBP) for imported medical devices. Use of the AofC codes is voluntary but recommended to avoid Customs delays. According to informal discussions with the FDA, proper use of AofC codes can reduce the Customs processing time from several days to a matter of minutes. We have listed some of the most commonly used AofC codes here.

These recommendations do not represent a change in policy or requirements, so manufacturers/importers should continue to provide the same information to customs as they have done in the past, but are encouraged to additionally include AofC codes.

Use of AofC codes does not involve any new registrations, licensing, or other official authorizations; it is simply a compilation and codification of information already available to manufacturers/importers.

Appropriate AofC codes should be determined by the manufacturer and/or importer and the necessary information should be compiled into a document and supplied to the customs broker (filer) or importer, who will ultimately provide the information to CBP.

All AofC codes relevant to medical devices are listed in the FDA Letter to Industry about "Import Entry Review Process" published March 24, 2011.

Determining Appropriate Codes

It is up to the manufacturer/importer to correctly determine the appropriate codes; errors or omissions will likely lead to Customs delays, so it is in everyone's best interest to determine the correct codes.

The Letter to Industry lists several codes that should be used for any device. These include codes that are common to all devices, such as listing number and initial importer Establishment Registration number. Additionally, several other codes may be applicable depending on the product.

In the case of the LWC and IRC codes (Lead Wire or Patient Cable, Impact Resistance Lens Certification), the Letter to Industry provides a list of specific product codes that fall into these groups. To determine if a product should be indicated with "LWC" or "IRC," simply look to see whether the device's product code is in one of the lists in the FDA's Letter to Industry under "ATTACHMENT - Product Codes for AofC IRC and LWC."

Once the appropriate codes have been selected, qualifiers should be determined where applicable.

Example AofC Code Usage

The following offers several hypothetical examples of the AofC codes that might be used for various products:

A Class II 510(k) cleared condom:
DEV-3055652389
DII-3001671145
LST- E100100
PMN- K102792

A Class I orthotic shoe:
DEV-3022652381
LST- E301200
MDL-OS808

Class II non-prescription sunglasses (product code 86 HQY—in IRC list):
DEV-322002381
LST-E306852
MDL-SUN1
PMN-K 874512
IRC

Using AofC Codes and Qualifiers

Some codes are used alone, while others require a "qualifier"; i.e., additional information appended to the code. For example, the AofC code for the device listing number is "LST" and requires a qualifier; thus, if your device listing number in FURLS were D104905, then you would use "LST-D104905" for the complete AofC code + qualifier. Other AofC codes are used alone without any qualifiers. For example, the "CPT" AofC code is used to indicate that the product is a device component; in this case, there is no associated number and only the AofC code would be used as "CPT." The List of Codes table indicates which codes require qualifiers and what each qualifier is.

Use of AofC codes is a simple way to facilitate prompt release from Customs. It can be done with minimal effort and at almost no cost. Manufacturers should share this information with their importers/brokers and develop a plan to implement use of this simple tool.

In our discussions with the FDA, it was emphasized that nothing has changed regarding Customs requirements; importers must continue to provide all the same information as they have historically, but may wish to include AofC codes for the benefit of a speedy release from Customs. Further guidance on import requirements is available in an article titled Importing into the U.S. on the FDA website.