Citing Shortages Tied To COVID-19, FDA Allows Some Alternative Flu Test Materials
The agency won’t require a 510(k) if manufacturers make some substitutions for materials now in high demand for COVID-19 tests.
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The US Department of Justice says the company provided advertising assistance and educational grants to health care providers that used its embolization devices.
The US FDA hopes to finalize or issue draft guidance documents on about 30 topics in fiscal year 2021.
On this week’s podcast: The US FDA was busy with draft and final guidance documents this week, issuing three within 24 hours. The docs address disparate device industry concerns, ranging from of-the-moment issues like coronavirus test supplies, to more traditional concerns around device materials testing.