| Title: | FDA Reminder Changes to Center of Devices and Radiological Health Product Codes |
|---|---|
| Date: | 2013-09-27 |
| To: | abi |
| Links: | previous, original, next |
TO: All ABI Filers
FROM: Food And Drug Administration
SUBJECT: Reminder from CSMS# 13-000441 FDA Changes to Center of Devices and Radiological Health Product Codes
This is a follow-up to the announcement of September 5, 2013 regarding the use of product codes.
In our prior communication, we had identified a number of product codes that would be deleted effective September 30, 2013. We wish to clarify the confusion that this statement may have caused.
The product codes from the September 5, 2013 announcement apply to devices that are not legally marketed. As a result, these product codes are not eligible for use to import legally marketed medical devices. If you have used one of the product codes on this list in the past, this was an error. In moving ahead, you should choose an eligible product code from our product classification database at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/PCDSimpleSearch.cfm.
If you have questions regarding the appropriate product code assignment for your legally marketed device, please contact Diane Garcia at Diane.Garcia@fda.hhs.gov.