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Patricia O'Connell
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Sonali Gunawardhana Discusses FDA’s Unique Identification Rule for Medical Devices

September 30, 2013

Sonali P. Gunawardhana, an attorney in Wiley Rein’s Food & Drug Law Practice, was interviewed by Law360 for a September 27 article about the U.S. Food and Drug Administration’s (FDA) new system for tracking the safety of medical devices.

The FDA released a final rule this month to phase the system in over seven years.  Under the rule, most medical devices sold in the U.S. will have to carry a unique device identification (UDI) code, with information such as the device model, serial number, and expiration date.

The FDA modified an earlier draft of the rule based on feedback from manufacturers.  While the original proposal would have required expiration dates to be formatted in the American “month-day-year” style, the FDA ultimately adopted industry’s recommendation for a “year-month-day” approach—consistent with international standards—to prevent disruptions to global commerce.

That revision is one of the most significant aspects of the final rule, said Ms. Gunawardhana, who previously served as regulatory counsel at the FDA’s Center for Devices and Radiological Health.  “Just having a date format that is global in nature is going to help many of these medical device companies,” Ms. Gunawardhana said. “No agency wants to be a barrier to trade.”

The final rule also requires companies to place UDI codes on the labels and packages of certain devices—rather than on the devices themselves, as the FDA originally proposed.  While it might become more realistic, as technology advances, to print codes on the tiniest implantable devices, the FDA was wise to hold off on that mandate for now, Ms. Gunawardhana said.

The agency also scrapped a proposal to require a new UDI code every time a device is updated with a minor modification. Under the final rule, a new code will only be required for changes that result in a new model or version of a device.  “To get a new UDI every single time you made some little tweak to it was going to be incredibly burdensome,” Ms. Gunawardhana told Law360.

The rule requires device companies to acquire the UDIs from FDA-accredited “issuing agencies.”  Manufacturers have raised concerns that only three such agencies currently exist, and the lack of competition could lead to high prices, according to the article.  The FDA said it reserves the right to revoke the accreditation of agencies that act in an anticompetitive manner.

“Some of the industry was concerned that oversight of those agencies would be tricky,” Ms. Gunawardhana said. “The bottom line is that the FDA has no control over their pricing.”