US FDA is providing some relief for manufacturers of most class I and unclassified devices that would require complying with the its Unique Device Identifier requirements. According to the agency, device-makers will now have an additional two years after new requirements come into effect (this year) before it decides to enforce them.
The agency's UDI regulations technically requires newly manufactured class I and unclassified medical devices to adhere to the agency's UDI labeling, Global UDI Database submission and standard date format requirements...