We have been recently getting a lot of queries regarding 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 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 figure out the rationale behind the 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. The following update talks about the where the FDA stands regarding the issuance of NDC/NHRIC labeler codes for medical devices
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 the 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. In 2016, the FDA released a guidance regarding the enforcement policy on NHRIC and NDC numbers assigned to devices. If a device is not required to bear a UDI on its label, any NHRIC or NDC number that was assigned to that device will be rescinded as of September 24, 2018 and should be removed from the device label and package but the FDA does not intend to enforce the prohibition against providing these numbers on labels and packaging until September 24, 2021. Please see Unique Device Identification System for the announcement.
Application of UDI:
In order to apply UDIs to your device labels, you 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 now applicable to Class III and Class II 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. The FDA has stated that neither inclusion in the NDC Directory nor assignment of an NDC number is a determination that a product is a drug as defined by the FD&C Act, nor does either denote that a product is covered or eligible for reimbursement by Medicare, Medicaid or other payers. The FDA doesn’t yet have a permanent solution for medical device manufacturers but they are working on it and will come up with some solution in near future for this issue.