FDA Pushes Back Enforcement of UDI Requirements for Class I, Unclassified Devices
The US Food and Drug Administration (FDA) said Friday that it will delay its enforcement of certain unique device identification (UDI) system requirements for class I and unclassified devices by two years.
A Federal Register notice on guidance released Friday, which FDA said takes effect immediately, said: "FDA does not intend to enforce standard date formatting, labeling, and Global Unique Device Identification Database (GUDID) data submission requirements under Agency regulations for these devices before September 24, 2020. In addition, FDA does not intend to enforce direct mark requirements under an Agency regulation for these devices before September 24, 2022."
The guidance, however, does not apply to implantable, life-supporting or life-sustaining (I/LS/LS) devices. FDA first discussed the push back of its enforcement the requirements in June.
Background
In 2013, FDA published a final rule establishing a UDI system to better identify devices through distribution and use. Phased implementation of the regulatory requirements was based on a series of established compliance dates based primarily on device classification, though many of the dates have been pushed back as questions from stakeholders have been raised.
FDA says its Global UDI Database contains 1.4 million records submitted by more than 4,000 device labelers.
The plan for a seven-year phase-in of the requirements, which has been pushed back, follows established compliance dates based primarily on device classification. For class II, class III and I/LS/LS devices, the compliance dates established for most UDI requirements have passed.
Guidance
The agency laid out the changes in its enforcement policy in the following chart in the 8-page guidance:
"As FDA and industry have worked to implement these requirements, the agency has identified complex policy and technical issues that require resolution to help ensure that UDI data are high quality and are available in standardized ways," the guidance said. "FDA received a large number of inquiries from labelers of class II, class III, and I/LS/LS devices relating to those policy and technical issues. Based on experience with UDI implementation to date, FDA anticipates receiving a similarly high volume of questions from labelers of class I and unclassified devices as compliance dates applicable to those devices approach."