| Title: | FDA Affirmation of Compliance code RB1 updated to no longer require a qualifier |
|---|---|
| Date: | 2013-04-05 |
| To: | abi |
| Links: | previous, original, next |
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
CSMS #13-000208