CDRH Aims for Flexibility, Gradual UDI Enforcement

The FDA plans to implement unique device identification requirements over several years, “and we fully expect and intend to be flexible during that time,” an agency source says.

“Our main focus is getting the UDI system implemented correctly and actively helping companies comply with system requirements — not on enforcement,” FDA spokeswoman Jennifer Rodriguez said.

“As with the implementation of many new systems, it can take time to understand and comply with new requirements. Widespread, strict enforcement of UDI system deadlines and requirements is not necessarily the best way to achieve compliance at this time,” Rodriguez adds.

Rodriguez says the agency has benefited from working with the device industry to implement UDI, and from companies’ feedback on the UDI program.

The FDA has granted “every reasonable request for an extension we’ve received from Class III labelers thus far, and urge those Class III labelers who haven’t fulfilled all UDI requirements to let us know they’re having problems,” she adds.

Sept. 24 is the deadline for labelers of Class III devices to display a UDI.

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