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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.

Performance measurement or level with caliper on computer notebook

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.

Last year, the FDA finalized a guidance that expanded its abbreviated 510(k) program that allowed some medical devices to be cleared by the agency if they met certain pre-determined performance...

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