FDA to Delay Enforcement of New UDI Labeling Requirements for Class I and Unclassified Devices
The Food and Drug Administration is delaying enforcement for two years of unique device identifier (UDI) requirements on class I and unclassified medical devices, it said Jan. 12 in a guidance document. For class I and unclassified devices, FDA will not enforce UDI labeling, data submission and standard date format requirements until Sept. 24, 2020. UDI direct marking requirements for class I and unclassified devices intended to be used more than once and reprocessed between uses won’t be enforced until Sept. 24, 2022, FDA said. Compliance with these requirements had previously been required in 2018 and 2020, respectively, under FDA’s 2013 UDI final rule (see 13092020).
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Despite the enforcement delay, FDA is not meaningfully changing provisions allowing devices manufactured before the relevant compliance date to be sold for three years without complying with UDI requirements, FDA said. Class I and unclassified devices manufactured and labeled before Sept. 24, 2018, will still be exempt until Sept. 24, 2021. Class I and unclassified devices manufactured and labeled before Sept. 24, 2018, will be exempt from direct marking requirements until Sept. 24, 2022, the same date as devices manufactured after Sept. 24, 2018, FDA said.
The enforcement delays don’t apply to class II and class III devices, as well as implantable, life saving and life sustaining (I/LS/LS) devices of any class (including class I and unclassified), because compliance with UDI requirements for these devices is already required. The delay for class I and unclassified devices comes in response to “complex policy and technical issues” discovered after these previous compliance dates, FDA 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,” it said. “To fully reap the public health benefits and a return on investment of the unique device identification system, the Agency intends to focus its resources on addressing existing implementation challenges and optimizing the quality and utility of UDI data for higher-risk devices before focusing on UDI implementation issues for lower-risk devices.”