FDA Ruling Targets Patient Safety, Improves Innovation

Medical device manufacturers are among the top innovators in the world, developing life-saving technologies at a pace that frequently outstrips that of other industries. Yet when the stakes are literally life or death, manufacturers must simultaneously uphold the highest standards in product quality and safety.

Regulations from agencies like the U.S. Food and Drug Administration provide a framework for this critical balance, and the newest regulatory requirement came earlier this month in the form of FDA UDI.

FDA UDI, or “unique device identification”, requires manufacturers of all medical devices—beginning with those that carry the highest risk to health and human safety—to identify their products with a unique number.

This 14-digit identification number must be displayed prominently on device labeling and packaging. In addition, no less than 65 key attributes of the device associated with the UDI number must be submitted, stored, and tracked in the FDA’s new GUDID, or “Global Unique Device Identifier Database”.

FDA UDI is paramount for both safety and innovation because it eliminates the current practice of renumbering medical devices in the field and improves communication between manufacturers, hospitals, doctors and distributors. This communication is a two-way street: including both the reporting of adverse events from end-users to manufacturers as well as the delivery of critical device information—like product recalls—from manufacturers to end-users.

Device renumbering is a huge problem for all involved, and creates a strain on resources and time. Worse yet, patient safety is compromised when medical device errors and product recalls cannot be communicated.

Clearer communications between end users and manufacturers around how devices are performing—including what needs to be corrected and improved—can also help to spur innovation. Information related to vital product changes can be delivered more quickly out to the field, improving the adoption of device innovations by doctors and hospitals.

In addition, the UDI ruling is designed to help reduce counterfeiting because the identity of products can be verified using the GUDID.

But FDA UDI will present new challenges for medical device firms too. It’s more than just a label on a package: it requires the collection, transformation, electronic submission, and management of vast amounts of product lifecycle data.

Because it is so vital to safety and innovation, a UDI must be traceable to both adverse events downstream and new product developments upstream: with a new or updated UDI submission required every time a product changes.

As this regulation goes live in the U.S., other worldwide regulatory agencies will quickly follow suit, creating a version of UDI with their own submission requirements.

For information on how to prepare for the UDI regulation, visit the UDI Resource Center. And stay tuned to this blog for more on how to solve the problem of UDI data management, FAQs on FDA UDI, and industry perspectives on the new regulation.

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