FDA Extends Deadline for Some UDI Requirements for Medical Devices
Posted 04 February 2016 | By
The US Food and Drug Administration (FDA) is giving manufacturers more time to remove drug codes from certain medical device labels in compliance with unique device identifier (UDI) requirements to avoid disrupting patient access to devices.
Specifically, the agency says it will enforce a statutory prohibition on National Health Related Item Code (NHRIC) or National Drug Code (NDC) numbers for device labels and packaging for certain devices.
In 2013, FDA issued its final rule for a UDI, requiring medical devices to bear a two-part identifier containing a device identifier and a production identifier. Under the rule, FDA established a seven-year phase in period for UDI compliance based on device class and type.
So far, adoption of UDI across the healthcare industry has proved to be a slow process. FDA has twice had to delay UDI implementation for certain products, and industry has fought against incorporating UDI into insurance claims forms, arguing that doing so would be costly and difficult.
NHRIC and NDC Numbers
As part of the broader transition to UDI, manufactures are prohibited under 21 CFR 801.57 from using NHRIC or NDC numbers, or "legacy FDA identification numbers," once a device is required to bear a UDI. Additionally, devices that don't require a UDI on their label are required to remove the legacy identifiers by 24 September 2018.
As FDA explains, "The rationale for these provisions is that the continued use of NHRIC and NDC numbers … could cause confusion regarding appropriate identification … or obscure the distinction between drug and device identification systems."
However, FDA says it has heard concerns from payers and pharmacies that the timeline for removing legacy identifiers could cause disruptions to reimbursement, supply chain, and procurement, "potentially interfering with patient access to devices."
To avoid these potential disruptions, FDA is giving manufacturers more time to transition away from NHRIC and NDC numbers for:
- Finished class III devices
- Devices listed under the Public Health Service Act (PHS Act)
- Class II devices
- Implantable, life-supporting or life-sustaining devices
However, this extension does not exempt manufacturers from any other aspects of the UDI Rule. While this policy will likely create some confusion by increasing the length of time some products bear multiple identifiers, FDA says the confusion is "outweighed by the threat of disrupting … patient access."
Enforcement Policy on National Health Related Item Code andNational Drug Code Numbers Assigned to Devices