Originally published in Medical Devices Law & Industry Report on 10/03/2012.

FDA’s New Plan -

The Food and Drug Administration (‘‘FDA’’) recently proposed a new system to track medical device malfunctions, increase patient safety and streamline product recall. On July 3, 2012, the FDA released its plan to label high-risk medical devices with tracking numbers, known as Unique Device Identifiers (‘‘UDIs’’). A UDI is a unique numeric or alphanumeric code, which operates ‘‘as a key to certain basic identifying information about a device, such as the name of the manufacturer, type of device, expiration date and batch or lot number.’’ This information will be available to the public on the FDA database.

According to the FDA, ‘‘the proposed rule reflects the considerable input the FDA received from the medical device industry, the clinical community, patients, consumers, and industry experts. To minimize industry costs and expedite implementation, the proposed system builds upon current standards and systems already in use by some companies.’’ FDA Commissioner, Dr. Margaret A. Hamburg, stated that the ‘‘safety of medical devices is a top priority for the FDA, Congress, industry and patients.’’ Commissioner Hamburg further declared that the ‘‘unique identification system will enhance the flow of information about medical devices, especially adverse events and, as a result, will advance [the FDA’s] ability to improve patient safety.’’ The UDIs will enable the FDA to access data maintained by government agencies, insurers and hospitals to determine which devices have a high degree of failure. Such product information will also be accessible to patients, doctors, industry regulators and consumer advocates.

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