UDI Rule for Medical Devices Finally Issued

Cheryl Clark, September 23, 2013

Hospital groups complain about the delay in rule-setting, the long implementation timetable for the unique device identifier rule, and a new database.

Manufacturers of the most potentially dangerous medical devices, such as pacemakers, external defibrillators, and certain implants, now have a timetable of Sept. 24, 2014 to label them for easier recall. The U.S. Food and Drug Administration's long-awaited final rule will allow adverse events to be more quickly investigated.

The label, called a unique device identifier or UDI, must be a unique number that includes the product's lot or batch number, expiration date, and manufacturing date, the rule says.

The one-year deadline is for Class III devices, generally defined as those that support or sustain human life or are essential for human health or prevent injury.

For Class II devices, such as infusion pumps, some non-invasive surgical materials, and electric wheelchairs, manufacturers have three years. The UDI deadline for Class I devices, considered the least likely to have quality issues or cause harm, such as bandages, is 2020.

The FDA also is launching the Global Unique Device Identification Database (GUDID), which the agency will administer. The database won't include specific patient identifying information, but in the rule the FDA said that it "plans to make most of the data reported under this rule available to the public."


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