advenamedical_product_safety_standard_consultancy

FDA relaxes UDI requirements for some Class I devices

The US Food and Drug Administration (FDA) has reviewed requirements for the use of Unique Device Identifiers (UDI) on low-risk Class I consumer health products. Other Class I products and unclassified devices will still need to meet the UDI requirements, however, their deadline has been extended to 8 December 2022.
Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices (fda.gov)