FDA Updates Template For Home COVID-19 Test Development
The US FDA’s most recent update is intended to help test makers provide validation data and other information to the agency for developing at-home diagnostic tests.
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The US agency made changes to two of its emergency use authorization templates “to support authorization of more COVID-19 tests” for over-the-counter use and to offer “flexible study recommendations.”
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News We’re Watching: CDRH’s Maisel Announces Retirement, Fresenius Clearance, Philips and Smiths Recalls
This week, a device center stalwart prepared to say goodbye; the FDA cleared Fresenius's 5008X Hemodialysis System; and class I recalls for Smiths Medical and Philips Imaging were announced.