| Title: | FDA Affirmation of Compliance Code Clarification of RB1 qualifier elimination |
|---|---|
| Date: | 2013-05-02 |
| To: | abi |
| Links: | previous, original, next |
Title: Clarification to CSMS#13-000171 – “FDA Affirmation of Compliance code RB1 updated to no longer require a qualifier.”
Date: 5/2/2013
CSMS#13-000171, dated 4/5/2013, indicated that if the FDA Affirmation of Compliance (AofC) code RB1 is used, it will no longer require a qualifier.
If the AofC code RB1 is transmitted to show that the rad health products comply with the U.S. federal performance standard, then the filer must also transmit a separate AofC code for either the most current annual report (ANC) or the product report (ACC) along with the Accession Number as the qualifier.
Example:
AofC Qualifier
RB1 (none)
ANC XXXXXXX
Or
AofC Qualifier
RB1 (none)
ACC XXXXXXX
For further information, please refer to the September 6, 2011, “Letter to the Industry About Import Entry Review Process”:
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm271180.htm