CSMS# 13-000208 - FDA Affirmation of Compliance Code Clarification of RB1 qualifier elimination
U.S. Customs and Border Protection sent this bulletin at 05/02/2013 06:35 PM EDTYou are subscribed to Automated Broker Interface for U.S. Customs and Border Protection. This information has recently been updated, and is now available.
05/02/2013 07:25 PM EDT
Automated Broker Interface
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
Related CSMS No. 13-000171
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
Related CSMS No. 13-000171
Update your subscriptions, modify your password or e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your e-mail address to log in. If you have questions or problems with the subscription service, please contact support@govdelivery.com.
This service is provided to you at no charge by U.S. Customs and Border Protection.
Privacy Policy | GovDelivery is providing this information on behalf of U.S. Department of Homeland Security, and may not use the information for any other purposes.
 |
 |