FDA’s Medical Device Ruling Calls for Rapid Compliance

At a recent doctor’s visit I had to list the medical history of my closest family members as part of a health profile. And that’s when it hit me: just how many of my loved ones are reliant on high-risk medical devices. For my family, that list includes one internal defibrillator, two cochlear implants, and no less than six replacement joints.

Reflect for a moment on your own friends and family, and your list will likely sound like mine. Our daily health and many emergency medical interventions rely on some highly advanced medical device technology.

There’s always some amount of risk associated with this kind of cutting-edge technology, which is why medical device manufacturers and the agencies that regulate them—like the US Food and Drug Administration (FDA)—must be experts at finding the balance between delivering life-changing technologies and minimizing patient risks.

This is why last month the FDA announced that medical device manufacturers are required to have a unique device identification system (UDI), which will allow for better tracking and therefore improved patient safety. Every unique medical device—including product versions, variants, and configurations—will receive a unique 14-digit identifier that’s filed in the FDA’s new Global UDI Database (GUDID).

The new ruling requires that every Class III medical device—those that are most critical to the health and safety of patients—be compliant by September of next year. Class II devices (those that are either implantable or otherwise higher-risk) and Class 1 devices must be compliant within two to five years.

UDI compliance involves more than just a label on the package displaying the device’s identification number. It also requires that 65 data points be gathered for every device and electronically submitted to the FDA’s new GUDID.

These data points need to be updated every time the associated product changes. For a company that may have thousands or even tens of thousands of devices, this is a huge undertaking. And even for companies that manufacture just a few devices, each device may have hundreds or perhaps thousands of variants that all require a UDI number and accompanying GUDID submission.

The FDA UDI rule stipulates that a UDI system must also be “21 CFR Part 11 compliant” (or in plain terms, must have a built-in capability for esignatures and more). In addition, manufacturers are required to have fully developed, documented, and executed internal training programs in time for their regulatory deadline.

Noncompliance comes with steep penalties. Enforcement of the FDA UDI rule will result in manufacturers being barred from selling non-compliant devices across state lines in the U.S. The risk of lost sales, potential fines, and even jail time is small compared to the risk to a company’s reputation if its devices do not comply in time.

Like our sense of urgency to protect our loved ones, medical device companies and the agencies that regulate them operate with a similar sense of haste to improve patient safety and lower patient risk.

To learn more about addressing the FDA UDI rule with an end-to-end technology solution, visit the UDI Resource Center, and check back soon to learn the FAQs of UDI and ways of solving UDI data management problems. Plus, get an industry perspective on UDI, and much, much more.

This entry was posted in Industry News, Medical Devices and tagged , , , , , . Bookmark the permalink.

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