FDA Issues New Guidance on UDI for Medical Device Manufacturers - The Blytheco Blog
FDA Issues New Guidance on UDI for Medical Device Manufacturers

FDA Issues New Guidance on UDI for Medical Device Manufacturers

The Food and Drug Administration (FDA) released a draft guidance document today, “Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices; Draft Guidance for Industry and Food and Drug Administration Staff.”

The guidance affects medical devices that are generally labeled with an 11-digit reimbursement number currently available through a pharmacy and potentially eligible for reimbursement from payers. This is typically a National Health Related Item Code (NHRIC) or National Drug Code (NDC) number.

The Unique Device Identification System final rule (UDI Rule) includes a provision (21 CFR 801.57) that rescinds any NHRIC or NDC number assigned to a medical device.

  • If a device is required to bear a UDI on its label, any NHRIC or NDC number assigned to that device is rescinded and may no longer be on the device label or on any device package on the compliance date established by the FDA in conjunction with the UDI Rule. The compliance date for when a device is required to bear a UDI on its label can be found on the Agency’s UDI Compliance Dates webpage.
  • If a device is not required to bear a UDI on its label, any NHRIC or NDC number assigned to that device is rescinded as of September 24, 2018, and may no longer be on the device label or on any device package.

When finalized, this draft guidance will describe the Agency’s intent not to enforce before September 24, 2021, the prohibition against providing NHRIC or NDC numbers on device labels and packages, with respect to class III devices, devices licensed under the Public Health Services (PHS) Act, class II devices, and implantable, life-supporting or life-sustaining devices, manufactured and labeled prior to September 24, 2018. In the draft guidance, the Agency is also proposing to extend the deadline to request use of FDA-issued labeler codes under a system for the issuance of unique device identifiers (UDIs) to September 24, 2018 (an extension from the 2014 deadline).

While implementing UDI requirements according to the scheduled UDI compliance dates is important to achieving the UDI Rule objectives in a timely manner, it is not our intent to disrupt existing reimbursement, supply chain, and procurement processes, or to potentially interfere with patients’ access to treatment. Additional time is appropriate for stakeholders to make changes to ensure that these processes will not depend on NHRIC and NDC numbers.

The FDA welcomes comments and suggestions regarding this draft guidance and says that the comment period will be open for 60 days.

For more information about the UDI System, please visit the FDA’s UDI webpage. If you have any questions, please contact the FDA UDI Help Desk.

For an overview of the UDI requirements, see our infographic, “The Medical Device Manufacturer’s Quick Reference Guide to UDI.”

Avatar for Kathy McCoy

Kathy McCoy, MBA, is the Demand Generation Manager at Blytheco. She has written on software and business management for more than 8 years and has more than 17 years of experience in business management.

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