FDA Releases Proposed UDI Rule
The U.S. Food and Drug Administration released on Tuesday its long-awaited proposed rule on unique device identifiers (UDI), which, if fully implemented, would overhaul how devices are labeled and, supporters say, enhance patient safety.
Consumer advocates, hospitals, and the device industry have been waiting for the rule since 2007, when Congress first directed the FDA to establish a UDI system, billing it as a way to more effectively track and recall problem products. In recent months, multiple lawmakers stepped up their pressure on the agency to release the draft rule..
The proposed rule would require manufacturers to place a numeric or alphanumeric code on their device that contains information such as model type, serial number, batch number, and expiration date, according to an agency announcement.
“The FDA is also creating a database that will include a standard set of basic identifying elements for each UDI, and will make most of it available to the public so that users of a medical device can easily look up information about the device,” according to an announcement posted on the agency’s website.. “The UDI does not indicate and FDA’s database will not contain any information about who uses a device, including personal privacy information.”
The agency says the UDI system will “provide a standardized identifier that will allow manufacturers, distributors, and healthcare facilities to more effectively manage medical device recalls.”
It can also help in addressing counterfeit devices, and allow more accurate reporting, reviewing, and analyzing of adverse event reports, the FDA says.
Consumers Union, the policy and advocacy division of Consumer Reports, welcomed the draft rule, calling it “long overdue.”
“Effective post-market surveillance of medical devices depends on having UDI in place,” Lisa Swirsky, senior policy analyst for Consumers Union, said in a statement.
The Federal Register expects to formally publish the rule later this week. After it is published, interested parties have 120 days to comment on it. To read the proposed rule, which is already posted on the FDA’s website, click here (PDF).
Posted: July 3, 2012