We have been recently getting a lot of queries whether or not FDA can still issue NDC/NHRIC labeler codes for medical devices with the recent advent of the new UDI (Unique Device Identification) regulations being implemented by the FDA.
The answer to this question is NO!!!
Some of the clients are arguing about the NDC labeler codes that have been issued in the past to some companies for medical devices like blood glucose strips and are trying hard to find out the rationale behind FDA stopping the issuance of these labeler codes. We understand that these questions are arising due to the problems many clients might be facing during reimbursement. Hence we contacted the FDA and got the most educated and formal response that we feel will throw a light on not all but majority of questions that are still in the minds of our medical device clients. The following update talks about the FDA stand’s regarding issuance of NDC/NHRIC labeler codes for medical devices.
1. NDC/NHRIC labeler codes for medical devices:
The FDA is no longer issuing new FDA labeler codes to device manufacturers. The FDA labeler codes are necessary to develop NDCs (National Drug Codes) – for the purpose of identifying drugs. The application of FDA labeler codes and NDCs/NHRICs (National Health Related Item Codes) to medical devices was an interim solution for device identification. As FDA announced on September 24, 2013, UDI is being phased in as the regulatory requirement for device identification, replacing NHRICs and NDCs when used only to identify a device. Please see Unique Device Identification System for the announcement.
2. Application of UDI:
In order to apply UDIs to your device labels, we will need to contact an accredited Issuing Agency.
mdi can help you with starting the UDI process for your devices by contacting the issuing agencies who will help you start the process of assigning identifiers and applying barcodes to your products and mdi will be maintaining the GUDID database for your medical device products and acting as a regulatory liaison with the FDA.
Please note that the UDI regulations are right now applicable only to Class III devices. Please see the summary of UDI Compliance Dates for all classes of medical devices.
For the purposes of reimbursement, FDA understands that the changes implemented from the UDI Rule change the practice of using NDC/NHRIC codes for reimbursement on medical devices. FDA doesn’t yet have solution for medical device manufacturers but they are working on it and will come up with some solution in near future for this issue.