| Title: | FDA Affirmation of Compliance (AofC) Codes for Medical Devices |
|---|---|
| Date: | 2011-04-14 |
| To: | abi |
| Links: | previous, next |
The Food and Drug Administration (FDA) is increasingly concerned with the number of imported medical devices that do not have sufficient entry information to allow the FDA to make a prompt admissibility decision. The Center for Devices and Radiological Health (CDRH), issued a letter, dated 03/24/2011, to the medical device industry regarding this matter. The letter provides specific recommendations to facilitate the import entry review process. These recommendations will directly immpact the filing of all entries of imported medical devices, electronic product components, parts and finished products into the U.S. Transmission of the necessary information, using the appropriate Affirmation of Compliance (AofC) codes and qualifiers, will help expedite the admissibility process based on FDA's automated screening process and prevent the need to hold the entry for further FDA review.
The CDRH letter to industry can be viewed at: http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm248321.htm.