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The US FDA hopes to finalize or issue draft guidance documents on about 30 topics in fiscal year 2021.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 US agency’s device center on 26 October published its A and B lists of guidance documents it will prioritize in fiscal year 2022, including drafting guidances to transition emergency use authorized products to full marketing status, and finalizing a clinical decision support software guidance that’s been four years in the making.
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.