FDA Finalizes First Two Guidances For 510(k) Pathway That Uses Performance Measurements
Executive Summary
The guidances outline testing and performance criteria for Foley catheters and cutaneous electrodes submissions through the new abbreviated 510(k) pathway.
You may also be interested in...
Priority Lane: Guidances On Risky Devices, 510(k) Reform Top FDA’s To-Do List
The US FDA hopes to finalize or issue draft guidance documents on about 30 topics in fiscal year 2021.
FDA Gives Insight On Changing Approval Landscape
Device center officials at the US agency focused on new approval pathways at RAPS Convergence 2020.
Consensus Standards: FDA Guidance Describes Recognition Process
The 13-page guidance document lays out what the agency looks for in deciding which consensus standards it can rely upon for premarket submissions.