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Home » FDA sustains definition of ‘easily readable’ in UDI form and content final guidance
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FDA sustains definition of ‘easily readable’ in UDI form and content final guidance

July 12, 2021
By Mark McCarty
The FDA’s draft guidance for the form and content of unique device identifiers (UDIs) may have lacked the controversy of some other policies, but the 2016 draft languished for five years even though only 10 comments appear in the docket. While the agency made some concessions regarding substantial edits of the draft, the final retains a need for data delimiters in the definition of “easily readable” plain text in UDIs, despite industry’s argument that this was not required in the agency’s UDI rulemaking.
BioWorld MedTech Regulatory Medical devices U.S. FDA

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