Affirmations of Compliance Codes (AofC Codes)

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.

Code Description Qualifier
CPT Device Component n/a
DEV Device Foreign Manufacturer Registration Number Establishment Registration number
DFE Device Foreign Exporter Registration Number Establishment Registration number
DII Device Initial Importer Registration Number Establishment Registration number
IDE Investigational Device Exemption Number IDE number
IFE Import for Export n/a
IRC Impact Resistance Lens Certification n/a
LST Device Listing Number Device listing number from FURLS
LWC Lead Wire or Patient Cable n/a
MDL Model Number Manufacturer's model number
PMA Device Premarket Approval Number PMA number
PMN Device Premarket Notification Number (510(k)) 510(k) number

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