FDA Schedules 2 More Virtual Town Halls In October For COVID-19 Diagnostics
The US agency has announced two additional webinars aimed at labs and manufacturers that are developing – or have developed – diagnostic tests for the coronavirus.
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King & Spalding quality expert Eric Henry urges device makers to be inspection-ready by making sure the right people are in the right roles.
The US FDA on 7 October recognized a portion of the Oncology Knowledge Base, or OncoKB, which test makers can use as they work to complete premarket submissions. It’s the first database of somatic variants in cancer to be listed in the agency’s Public Human Genetic Variant Databases.
Thousands of procedure packs made by DeRoyal Industries Inc. are being recalled because they include a NORMOFLO Irrigation Warming Set that was the subject of a recent high-risk class I recall by manufacturer Smiths Medical because the device may leach aluminum.