CSMS# 14-000204 - Title: FDA Affirmation of Compliance Code update
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04/10/2014 12:23 PM EDT
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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
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
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