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The US FDA hopes to finalize or issue draft guidance documents on about 30 topics in fiscal year 2021.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 Department of Justice says the company provided advertising assistance and educational grants to health care providers that used its embolization devices.
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.
The agency won’t require a 510(k) if manufacturers make some substitutions for materials now in high demand for COVID-19 tests.