| Title: | FDA Affirmation of Compliance Code update |
|---|---|
| Date: | 2014-08-28 |
| To: | abi |
| Links: | previous, original, next |
As previously announced (CSMS Message #14-000204), FDA is using a new numbering system for medical device De Novo applications. Because of this change, the appropriate qualifier for the Affirmation of Compliance (AofC) code PMN will either be K followed by 6 digits or DEN followed by 6 digits. For example:
AofC Code Qualifier
PMN K011234
PMN DEN010123
In addition, previously-granted DeNovo applications with 510(k) numbers have been reassigned DEN numbers. Filers will need to make any necessary adjustments to reflect the new DEN numbers. The list of DEN numbers and legacy 510(k) numbers can be accessed via this link: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?start_search=1¢er=CDRH&DeNovo=on&PAGENUM=500 . The list may then be exported to Excel or downloaded for reference.