It took five years, but the U.S. FDA has finally issued the proposed Unique Device Identification(UDI) rule that will require manufacturers of medical devices to uniquely identify their products and populate FDA’s global UDI database (GUDID). Orthopaedic manufacturers will be among the first impacted, as early as 2014.
What is the Purpose of UDI?
Creation of a UDI system was mandated as part of the FDA Amendment Acts (FDAAA) of 2007, but the concept dates back to the 1999 To Err is Human report, which found that as many as 98,000 people die in hospitals each year as a result of preventable medical errors. In an effort to minimize medication errors, the FDA issued the medication barcode rule in 2004 to make it possible for clinicians to scan barcodes to verify that the right drug in the right dose and right route of administration is being given to the right patient at the right time. The rule, which went into effect in 2006, requires certain human drug and biological product labels to contain a linear bar code consisting of the National Drug Code (NDC). At the time, the FDA Center for Devices and Radiological Health (CDRH) wanted to create a similar rule for medical devices, only to find that there was not a comparable standard identifier, like the NDC, for devices. That set the wheels in motion for inclusion of language mandating UDI in the FDAAA.
Orthopaedic device manufacturers will need to comply with UDI by September 24. Learn best practices for implementation and how to maximize your value from the mandated investment at OMTEC 2014. Karen Conway and executives from Medtronic and Johnson & Johnson will share compliance strategies during the UDI Knowledge Center.
What is UDI? What will you need to do to comply? And by when?
The proposed UDI rule was published in the Federal Register on July 10, 2012, which kicked off a 120-day comment period that ends on November 7, 2012. Also in July, President Obama signed the FDA Safety and Innovation Act (FDASIA); it requires the final UDI rule to be issued within six months after the close of the comment period, which would be May 2013. If the timelines included in the proposed rule stand, manufacturers of Class III devices, which include orthopedic implants, will need to carry the unique identifiers on their labels within 12 months after the final rule is published, or likely May 2014. The next batch of covered products is what FDASIA describes as “devices that are implantable, life-saving, and life-sustaining.” They must bear the unique identifiers within 24 months after issuance of the final rule or May 2014; Class II products follow a year later and non-exempt Class I devices three years later.