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Final FDA rule sets up UDI system for medical devices

The U.S. Food and Drug Administration (FDA) released its long-awaited final rule for unique device identification (UDI) system for medical devices, which will make recalls more straightforward and better organize adverse event reporting – all in an effort to improve patient safety.

The rule centers around two core items, the first of which requires a unique number to be assigned to every model of a medical device. Secondly, the rule will create a public database of medical devices. The FDA hopes these steps will help them more quickly identify specific medical device malfunctions and assess whether a recall is needed.

The final rule comes more than a year after the FDA’s Center for Devices and Radiological Health issued a report calling for greater postmarket surveillance of medical devices. In the report, the “National Medical Device PostMarket Surveillance System,” the FDA asked for cooperation from medical facilities and recommended the establishment of a UDI system. The report also cited the likelihood that medical device usage could be recorded in EHR systems, necessitating the creation of a standard to regulate the devices themselves.

In addition to collection public comments after issuing its preliminary report a year ago, the FDA also established a website intended for patients to submit feedback on medical devices and prescription drugs. The site includes information explaining the process behind drug and medical device development, from the research stage to FDA post-market monitoring.

The FDA has other issues at hand regarding medical devices. Earlier this year, they released draft guidance on securing medical devices, which are targeted by hackers and prone to malware infections due to their simple operating systems. The report detailed that the FDA had received reports of medical devices affected or disabled by security threats. They cautioned that more threats are on their way, to which new and legacy devices are vulnerable. mHealth app developers also anticipate new, deeper guidance based on the 2011 Medical Device Data Systems (MDDS) rule, which some complain was too vague and stifles innovation. Clarifications rumored to be in the works may open the floodgates to new app development.

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