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FDA Will Relax Premarket Requirements To Enable LVAD Randomized Trials

This article was originally published in The Gray Sheet

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Executive Summary

Randomized, controlled trials supporting PMAs for left-ventricular assist devices as destination therapy should compare the investigational device with an already approved LVAD, according to FDA

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Warning Letter Roundup & Recap – 26 January 2021

No device-related warning letters were released by the US FDA the week of 26 January.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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