| Title: | Title: FDA Affirmation of Compliance Code update |
|---|---|
| Date: | 2014-04-10 |
| To: | abi |
| Links: | previous, original, next |
Starting in June 2014, FDA will be using a new numbering system for medical device De Novo applications. Because of this change, the appropriate qualifier for the existing Affirmation of Compliance (AofC) code PMN will either be K followed by 6 digits or DEN followed by 6 digits. For example:
AofC Qualifier
PMN K011234
PMN DEN010123
Filers are encouraged to confirm that their ABI software allows them to transmit a 9-character qualifier for the AofC code PMN, and to make any necessary adjustments before June 2014.
Please send any questions or concerns to cdrhocimport@fda.hhs.gov
CSMS #14-000482