The Medical Technology Blog

FDA unveils plans for device ID system for medical devices


Welcome back to the Medical Technology Blog, we have a great post today provided by our medical newsletters team-leader, Lawrence Miller. Lawrence is the editor for Medical Industry Week, please read on…

FDA proposal

In response to requirements in legislation that passed US Congress, the FDA has proposed that most medical devices distributed in the US carry a unique device identifier (UDI) in a move aimed at improving the quality of information in medical device adverse events reports.

The plans, which are now the subject of a 120 day comment period, aim to help the FDA identify product problems more quickly, better target recalls and improve patient safety. So far, the agency has conducted four pilot studies in the development of this proposed rule. With certain exceptions, under the proposed rule, a UDI would include a device identifier, which is a unique numeric or alphanumeric code specific to a device model; and a production identifier, which includes the current production information for a device.

Risk-based, phased-in

The FDA is proposing a “risk-based, phased-in” approach to implementation, focusing on the highest-risk medical devices first and exempting low-risk devices from some or all of the requirements. The agency is proposing to exempt OTC devices sold at the retail level as these devices generally have UPC codes in place.

A UDI acts as a key to certain basic identifying information about a device, such as the name of the manufacturer and the type of device, and may represent certain other information about the device, such as its expiration date and batch or lot number. This information will be contained in a publicly available UDI database called Global Unique Device Identification Database (GUDID), which will not contain any identifiable patient information.

The plans target the more accurate reporting, reviewing and analysing of adverse event reports so that problem devices can be identified and corrected more quickly. Other benefits include a reduction in medical errors and better management of medical device recalls.

Article Source: Medical Industry Week (MIW)

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