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BioWorld - Tuesday, December 30, 2025
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Home » The FDA may exercise enforcement discretion for UDI requirements for some class I devices
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The FDA may exercise enforcement discretion for UDI requirements for some class I devices

Oct. 13, 2021
By Mark McCarty
The FDA’s device center has posted a draft guidance that addresses unique device identifier (UDI) code requirements applied to low-risk products. The select update offers enforcement discretion in some instances for class I consumer health products, a switch partly justified by the exceedingly low risk presented by such products.
BioWorld MedTech Regulatory U.S. FDA

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