FDA Proposes Rule on Device Tracking System: What Should We Expect?
Language in the “must pass” U.S. Food and Drug Administration (FDA) funding bill calling for a “track-and-trace” system for medications was scrapped by Congress in June.
But breast implants, implantable pacemakers, powered wheelchairs, pregnancy test kits and other medical devices may face a different fate.
Just last month, the U.S. Food and Drug Administration (FDA) published a proposed rule requiring most medical devices distributed within the United States to carry a unique device identifier (UDI). The proposed system, which comes five years after Congress mandated its creation, is aimed at improving product tracking and identifying safety problems before they escalate.
The agency also believes that the use of UDIs on medical equipment would significantly enhance device recall efforts when effectively implemented into a company’s product recall procedures.
With the public comment period on FDA’s proposed rule ending in November 2012, what would this system mean for those within the industry? How would such a program be introduced and implemented?
Under the new rule, medical equipment makers would be required to label a UDI, a unique numeric or alphanumeric code, on most of their products. This code, which is specific to a device model and a production identifier, would be printed on device labels and packaging. It would also be directly placed on implantable devices.
Over-the-counter or low-risk devices, such as bed pans and examination gloves, would be exempted from this requirement.
The individual codes would then be entered into an FDA-created online public database, allowing users of medical devices to look up product information. This would also permit physicians and regulators to identify safety problems associated with particular devices and inform affected patients.
Should FDA’s proposal be approved, the UDI system would be phased in over several years. For instance, Class III devices including pacemakers and implants would be required to add identification codes within one year after the law took effect. Class II devices, such as infusion pumps and surgical drapes, would have to incorporate UDIs within three years after the law is finalized, meaning 2015.
The agency is scheduled to make a final ruling with regard to the UDI system within six months after the comment period comes to an end.
Do you believe the FDA’s proposed tracking system would benefit the medical device industry? What changes will you need to make to your product recall procedures should this system be implemented? We welcome your comments below.
Stericycle ExpertRECALL™ is the industry leader in recall logistics and regulatory compliance for consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertRECALL’s professionals are experts in recall management who can help you streamline the entire product recall process.