CSMS Message: 16-000821

Based on feedback received, FDA has added the following OPTIONAL Affirmation of Compliance for medical devices and radiation emitting products:
ERR Entry Review Requested (no qualifier)

In addition, the following OPTIONAL Affirmation of Compliance is now valid for radiation emitting products:
IFE Import For Export (no qualifier)

For medical devices, DDM (Device Domestic Manufacturer) is no longer mandatory under Intended USE Code 170.000. When transmitting Intended Use Code 170.000, repair of medical device and re-exportation, DDM is now CONDITIONAL: DDM should be supplied if the facility is registered.

The next version of FDA's Supplemental Guide will include these changes.

For radiation –emitting devices, when declaring the affirmation “RB1” (Rad Health Product Affirmation B-1), many filers are transmitting this incorrectly with a qualifier. Example: “RB1 X-RAY TUBE” or “RB1 N/A.” This is incorrect. When declaring RB1, no additional text is needed as a qualifier. The declaration “RB1” is all that is needed for this Affirmation of Compliance. When you transmit “RB1” you will also need to transmit the Affirmation of Compliance ACC or ANC and the qualifier number.

As a reminder, for medical devices, FDA/CDRH highly encourage the use of the FEI number along with the PG19 entity information. To obtain the FEI number for medical devices, visit CDRH's public website: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm and type in the registration number or establishment name. Providing the FEI will expedite FDA processing.

For questions related to these topics or other ACE-related issues, please contact FDA ACE Support 24/7 at ACE_Support@fda.hhs.gov or 877-345-1101.