| Title: | FDA Affirmation of Compliance for Electronic Products |
|---|---|
| Date: | 2010-03-18 |
| To: | abi |
| Links: | previous, next |
The FDA has created a new Affirmation of Compliance (AofC) code for use in identifying manufacturers of electronic product components that will be incorporated into finished products. Use of this code is important to expedite our automated database look-up for components transmitted to FDA using product codes for a finished product. Failure to transmit this code will result in entries being held for manual review.
AofC Code AofC Description
CCM 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.