FDA Scraps Trump-Era Plan To Let Dozens Of Devices Skip Premarket Review

By Kelly Lienhard / April 15, 2021 at 6:23 PM
FDA announced Thursday (April 15) that it is withdrawing the list of 83 class II devices and one unclassified device type that the Trump administration had proposed to permanently exempt from 510(k) premarket review, after health care providers and industry both said the proposal posed patient safety and access concerns. The Trump-era notice , published Jan. 15, called for the temporary exemption from the 510(k) pathway offered during the COVID-19 pandemic to be permanently extended for seven class I devices,...

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