The compliance deadline for high-risk Class III devices as part of the U.S. Food and Drug Administration’s (FDA) Global Unique Device Identification (UDI) rule is September 24, 2014. The FDA’s UDI rule aims to dramatically reduce the instances of patient injury and death that result from the misidentification of medical devices. In addition to labeling products with UDI-compliant codes, manufacturers of covered products must publish additional data on those products to the FDA’s Global UDI Database (GUDID). The next meeting of the GHX Global Data Standards Users group will focus on the requirements and processes for submitting data to the GUDID via a third party. The users group is scheduled for Thursday, July 17 from 10-11 a.m. ET.
With just 10 weeks remaining for manufacturers to submit data to the FDA’s Global UDI database, manufacturers must quickly understand the intricacies surrounding UDI data quality and regulatory submissions. In May, GHX announced it was broadening its existing UDI consulting and data services to include the PTC UDI Solution for creating, communicating, and tracking 21 Code of Federal Regulations Part 11-compliant Global UDI Database (GUDID) submissions. Representatives from GHX and PTC will discuss GUDID requirements and processes, and engage in an industry dialogue to help promote faster learning around this issue as the first deadline looms. After this year’s deadline, all Class III implantable devices will need to comply with the rule by September 2015, with Class II and Class I products to follow in subsequent years.
For more than a decade, GHX has worked together with hospitals and manufacturers to synchronize product data, helping build a foundation of greater accuracy for e-business transactions. Today, GHX operates the largest, most accurate and up-to-date product content repository in healthcare, helping to ensure GHX customers are always moving toward greater automation and efficiency. With the addition of the PTC UDI solution capabilities, GHX now offers manufacturers an even more comprehensive set of Global Data Standards compliance offerings, helping satisfy their product data standardization needs for both customers and regulators.
The GHX Global Standards User Group was created to provide GHX members with a forum to learn more about global data standards, their impact on healthcare and how to work with GHX to enable their use. The group holds a monthly, online meeting to provide support, share best practices and keep abreast of the latest news and events.
For more information or to register for the free July 17 online session, email GHXStandardsUG@ghx.com.
About GHX
Global Healthcare Exchange, LLC (GHX) is driving costs out of healthcare by transforming the healthcare supply chain. Working with providers and suppliers, GHX is accelerating change by providing a faster, more efficient and collaborative supply chain that will take billions of dollars out of the cost of healthcare. For more information, visit www.ghx.com and the company’s healthcare blog The Healthcare Hub, http://www.thehealthcarehub.com.