Understanding the FDA’s Proposed UDI Requirement
For many years the Food and Drug Administration (FDA) and industry partners have been studying the benefits associated with automatic-identification technologies that have been deployed in both healthcare and non-healthcare industries.
With this proposed requirement, the FDA is reinforcing the importance of these technologies developed by organizations like HIBCC in support of enhanced safety and cost containment strategies.
We have answered a few common questions about the FDA UDI proposal here, but to read the complete HIBCC Guideline to the FDA’s proposed UDI requirement, download this PDF.
What is a UDI?
The Unique Device Identifier (UDI) is a system used to mark and identify medical devices within the healthcare supply chain. The proposed FDA rule will establish a UDI system that requires manufacturers to include both a plain-text version of the identifying data and a version encoded using Automatic Identification Data Capture (AIDC) technology such as linear/two-dimensional bar codes, RFID tags, etc.
What comprises a UDI?
The FDA has stated that a UDI will be comprised of two parts:
- An identifier of the specific model and labeler (usually the manufacturer) of the device;
- As required based upon the class of device, a production identifier that may potentially include lot/batch of manufacture, serial number, and/or expiration date or date of manufacture.
What are the benefits of a UDI system?
The FDA and its partners believe that the implementation of UDIs and AIDC systems can help reduce the incidence of medical error, thereby enhancing patient safety efforts, and can also assist with streamlining supply chain processes, reducing costs to all parties. The FDA outlines several public health objectives they believe will be served by this rule:
- Reduction of medical errors
- Integration of device usage data.
- Faster device identification in event of adverse event or recall.
How do HIBC Labelers comply with the requirement?
The thousands of current and future HIBC Labelers are already a long-way to complying with the proposed regulation, as the HIBCC Supplier Labeling Standard (HIBC SLS) has been identified by FDA as an acceptable UDI format.
How do manufacturers become HIBC Labelers?
The process is simple. First, organizations must apply for a Labeler Identification Code (LIC) assignment by submitting an application on-line, by mail or by fax.
What are the main advantages of using the HIBC Standard for UDI?
Safety, cost and flexibility. For more details read our guideline to the FDA’s proposed UDI requirement.
Create a HIBC UDI
The ‘UDI Generator Utility’ provides users an easy, on-line formatter to quickly enter the required data fields and create the resulting HIBC-UDI in an FDA compliant format. Click Here to create HIBC-UDIs.
Contact HIBCC for additional information
If you want to begin planning for the implementation of UDI, HIBCC is your resource for information on the FDA’s proposed rule. If you have comments or questions for HIBCC, or for the FDA, please contact us via our contact form or call us at 1-855-HIBC-UDI.