Almost a year after creating a new Safety and Performance Based Pathway for 510(k) eligible products, the US Food and Drug Administration has finalized the first guidances for acceptable performance criteria, covering Foley catheters and cutaneous electrodes.
FDA Finalizes First Two Guidances For 510(k) Pathway That Uses Performance Measurements
The guidances outline testing and performance criteria for Foley catheters and cutaneous electrodes submissions through the new abbreviated 510(k) pathway.
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