The US Food and Drug Administration (FDA) has extended the compliance deadlines for the unique device identification (UDI) system requirements for certain class I and unclassified medical devices from September 24, 2018 to September 24, 2020.
UDI requirements for class III; implantable, life-supporting or life-sustaining (I/LS/LS); and class II devices have already been implemented by the FDA and industry. Numerous device labels now display UDIs, and the FDA’s Global Unique Device Identification Database, GUDID, is already a large repository of device identification information.
The FDA plans to engage with industry and other stakeholders to address existing challenges associated with implementing UDI and optimize the quality and utility of the data for higher-risk medical devices already in GUDID before adding lower-risk medical devices.
In order to extend the compliance dates for lower-risk medical devices, the FDA intends to issue a guidance document to provide an enforcement discretion policy for labeling, GUDID data submission, standard date formatting and direct mark requirements for certain class I and unclassified devices. This enforcement discretion policy will not apply to class I or unclassified implantable, life-supporting or life-sustaining devices as labelers of these devices must already comply with UDI requirements. Contact us
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