As COVID-19 continues to impact the medical device sector, the U.S. FDA has delayed compliance deadlines for its universal device identification (UDI) system for Class I and unclassified medical devices—other than implantable, life-supporting, or life-sustaining equipment.
The updated UDI policy, issued last month via an immediately in effect guidance, “presents a less burdensome policy that is consistent with public health,” according to the FDA.
The guidance document, Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marketing establishes that in addition to UDI labeling, standard date formatting and submission of device information to the FDA database for Class I and unclassified devices won’t be enforced before Sept. 24, 2022, as will compliance with the additional direct marking requirement for reprocessed and reusable devices. The new dates are in effect regardless of when a device was manufactured and labelled.
Read the full article on AAMI’s website.