The FDA implemented the UDI Rule, which established the unique device identification system, on September 24, 2013.
The FDA’s new proposed guidelines follow news that the number of medical devices expected to meet these tracking regulations will grow this fall, according to The Hill.
Here are four things to know about the draft guidance:
- To improve the tracking of medical devices throughout their distribution and use, the FDA is gradually adding requirements for unique device identifiers to be used on everything from pacemakers to condoms.
- A UDI contains the device’s specific model information, as well as data for up to five production elements, like serial number or expiration date.
- The draft guidance explains that the UDI is required on the medical device in two formats — a plain-text version and an automated version that can be added to a patient’s EHR.
- The draft guidance also clarifies how the information in UDIs should be ordered and presented. The FDA’s current UDI rule does not require the automated identifier to be in a specific form or made by a certain technology. The new guidance requires the automated marker to be in a format that can be read by a barcode scanner.
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