CSMS# 13-000171 - FDA Affirmation of Compliance code RB1 updated to no longer require a qualifier
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04/05/2013 12:35 PM EDT
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The Food and Drug Administration (FDA)has made a change to their Affirmation of Compliance (A of C) Code RB1. No qualifier is required when transmitting this code. Transmitting this code without a qualifier will no longer result in a reject by ACS.
Code Description
RB1 RAD HEALTH PRODUCT DECLARATION B1 (FDA 2877)
Please see information about additional Affirmation of Compliance Codes which should also be transmitted along with A of C RBI.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm271180.htm
FDA contact regarding this message is cdrhocimport@fda.hhs.gov
The Food and Drug Administration (FDA)has made a change to their Affirmation of Compliance (A of C) Code RB1. No qualifier is required when transmitting this code. Transmitting this code without a qualifier will no longer result in a reject by ACS.
Code Description
RB1 RAD HEALTH PRODUCT DECLARATION B1 (FDA 2877)
Please see information about additional Affirmation of Compliance Codes which should also be transmitted along with A of C RBI.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm271180.htm
FDA contact regarding this message is cdrhocimport@fda.hhs.gov
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