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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The US FDA hopes to finalize or issue draft guidance documents on about 30 topics in fiscal year 2021.
Device center officials at the US agency focused on new approval pathways at RAPS Convergence 2020.
The 13-page guidance document lays out what the agency looks for in deciding which consensus standards it can rely upon for premarket submissions.