US FDA Extends UDI Deadlines For Low-Risk Devices

16 Jan 2018

The agency slowed down its effort to require the overwhelming majority of medical devices to adopt Unique Device Identifiers with a new guidance that would in delay full implementation of the UDI system for lower-risk devices.

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...

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