The Food and Drug Administration issued its long-awaited proposed rule on unique device identifiers. The FDA is proposing that most medical devices distributed in the U.S. will be required to participate in the UDI system, which will help the agency better track and collect safety data about medical devices. It has spent about $1.5 million to develop a database to house the information the system gathers.
“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,” FDA Commissioner Dr. Margaret Hamburg said in a news release.
The proposed rule exempts some devices, such as low-risk devices like bedpans and other over-the-counter products, and will require implementation for high-risk devices first.
Participating devices will be given a device identifier, which is a unique numeric or alphanumeric code for a device model, and a production identifier, which includes information such as lot or batch number, serial number or expiration date.
High-risk devices will be required to have a UDI on the label and packaging within one year after the final rule and on the device itself within three years, said Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, during a call with reporters.
He said the UDI system is the “cornerstone” of a modern post-market surveillance system for medical devices.
Congress had originally passed legislation in 2007 that required the FDA to develop UDI regulations. A proposed rule was submitted to the Office of Management and Budget last year, where it has been held. The delay prompted Sens. Herb Kohl (D-Wis.), Chuck Grassley (R-Iowa) and Richard Blumenthal (D-Conn.) to call for the rule’s release back in February.
More recently, lawmakers passed user-fee reauthorization legislation that requires the agency to implement the UDI system for high-risk medical devices within two years of the final rule.
In a statement, the Premier healthcare alliance said the proposed UDI system will enhance adverse-event reporting, improve the recall process, and save billions of dollars by automating manual processes and improving efficiencies. However, the organization questioned the FDA’s proposed timeframe.
“Since we have already been waiting five years for UDI, patients can’t wait until 2019 to have confidence that the devices implanted in their bodies are safe and effective,” said Blair Childs, senior vice president of public affairs, in the statement. “Moreover, a long timeline is not in line with congressional intent in the recently passed Food and Drug Administration Safety and Innovation Act, which called for a two-year implementation timeline for life-saving and implantable devices.”
The comment period ends in 120 days.
CLICK HERE for the proposed rule as a PDF file.
CLICK HERE for the FDA press announcement.