Products Liability Prevention & Defense

FDA Issues New Draft Guidance Requiring Modifications to Medical Device Tracking Labels

medical equipment with labelThe Food and Drug Administration released draft guidance last week revealing its intent to better track medical devices, from pacemakers to condoms, through an amendment to its 2013 “UDI (unique device identifier) Rule”.  The draft guidance is intended to assist both labelers and FDA-accredited issuing agencies to better ensure the UDIs are in compliance with the Rule.  The UDI Rule established a tracking system to adequately identify devices through distribution and use throughout the United States.  Under 21 CFR 801.20, a UDI is required on the label and package of every medical device in commercial distribution in the United States (unless an exception or alternative applies). 

A UDI indicates the specific model and information on up to five production elements, such as the serial number, expiration date or date the device was manufactured.  The new guidance clarifies that the UDI is now going to be required in both plain-text and automated versions to enable adding the device directly to a patient’s electronic health record or other computer system and “minimize errors in records resulting from manual transcriptions”.  It also sets guidelines for how the information on the UDI should be ordered.  For instance, while the 2013 UDI regulation does not require the automated identifier to be in a specific form or created by a specific technology, Monday’s guidance clarifies that the automated marker should be in a format that can be read by a barcode scanner or similar technology.  If space is limited, the guidance provides that the automated marker may be broken up into multiple segments – although specific model information must come before production information.  Labelers may also choose to incorporate more than one type of automated transmission technology – such as a linear barcode and a data matrix code (2-D) on the device label, both representing the same UDI so long as a plain text label is also included.  Labelers can even choose to utilize automated technology that is not visible to the human eye, like RFID codes for example, so long as the label or device discloses the presence of such technology.  While notice of the use this type of technology is required, the FDA does not specify the type of marking or symbol, which is intended to provide labelers “greater flexibility and reduced burdens”.

Currently “implantable, life-sustaining, or life-supporting devices” that are intended to be used more than once are required to include UDIs on their packages and the device itself.  Class III devices, which have the highest risk, such as pacemakers, are also required to have UDIs on their packaging.  According to this new draft guidance, Class III devices will also need to show the UDI on the device itself, and the package labeling requirements will extend to Class II devices, which include for example, condoms, endoscopes and tampons.

This proposed guidance is open for public comment for 60 days.

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