FDA clarifies medical device tracking rule

FDA clarifies medical device tracking rule
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The Food and Drug Administration released draft guidance on Monday for identification tags that will track medical devices from manufacturers to users.

The guidelines come as the number of medical devices required to meet the tracking regulations is expected to grow this fall.

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The agency is phasing in requirements for unique device identifiers (UDIs) in an effort to better track medical devices, from pacemakers to condoms. 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 guidance clarifies that the UDI is required in two formats: a plain-text version and an automated version that can be added to a patient’s electronic health record or other computer system. It also sets guidelines for how the information on the UDI should be ordered.

For example, FDA’s UDI rule, issued in 2013, does not require the automated identifier to be in a specific form or created by a specific technology. But 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 on the package or device is limited, the guidance would allow the automated marker to be broken up into multiple segments, though information about the specific model must come before production information.

The draft guidance will be open for comment for 60 days.

The tracking system is in the third year of a seven-year rollout. 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. By Sept. 24, Class III devices also must show the UDI on the device itself, and the package labeling requirements will extend to Class II devices, which include condoms, endoscopes and tampons.

This story was reported by The Hill Extra: Healthcare, launching this fall with subscriber-only access to breaking news and insider analysis of policy, regulation and legislation.