FDA Proposes ID System for Medical Devices
Jul 09, 2012 |
The U.S. Food and Drug Administration has proposed a rule for adding unique identifiers to most medical devices distributed in the United States.
"The safety of medical devices is a top priority for the FDA, Congress, industry, and patients," says FDA Commissioner Margaret Hamburg. "The unique identification system will enhance the flow of information about medical devices, especially adverse events and, as a result, will advance our ability to improve patient safety."
Labelers of medical devices would incur most of the costs of the proposed rule, says the FDA. The agency expects that labelers — which include manufacturers, reprocessors, specification developers, repackagers and others — would pay as much as $571.5 million over 10 years to comply with the rules as drafted.
The system has the potential to improve the quality of information in medical device adverse events reports, says the FDA. Better tracking would help the agency identify product problems more quickly, better target recalls, and improve patient safety, it says. Furthermore, the identifiers could help route out counterfeiting and provide a consistent way to enter information about devices in electronic health records and clinical information systems.
The identifiers would be linked to information such as the name of the device’s manufacturer, the type of device, and its expiration date and batch or lot number, information that would be kept in a publically available database, under the proposed plan.
The FDA is proposing a risk-based, phased-in approach to implementing the identifier system, focusing on the highest-risk medical devices first and exempting low-risk devices from some or all of the requirements. Over-the-counter devices sold in stores would generally be exempted from the rules, because they usually carry a universal product code.
The proposal released July 3, is available for comment until the end of October.
Copyright 2012 Burrill & Company. For more life sciences news and information, visit www.burrillreport.com.