MedTech Dive July 7, 2021
Dive Brief:
FDA has finalized guidance on the form and content of unique device identifiers used to track medtech products through the supply chain.
The final text responds to, but in some cases holds firm against, concerns raised by groups including AdvaMed about the 2016 draft, such as changes to the wording about the inclusion of data delimiters in the easily readable plain-text form of the UDI.
FDA has also added a new section to the final guidance. The section covers UDI requirements for standalone software that is not distributed in packaged form.
Dive Insight:
The guidance is intended to ensure UDIs meet the objectives set out in FDA’s final rule on...
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