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The US FDA hopes to finalize or issue draft guidance documents on about 30 topics in fiscal year 2021.
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The guidances outline testing and performance criteria for Foley catheters and cutaneous electrodes submissions through the new abbreviated 510(k) pathway.
The US FDA is updating its labeling guidance on laparoscopic power morcellation to reflect new evidence showing the treatment may pose a higher cancer risk in older women, as well as to add discussion of containment systems.
A US FDA panel unanimously agreed that surgical staplers should be reclassified into class II on 30 May, backing FDA recommendations.