FDA Warns About Counterfeit COVID-19 Tests
Counterfeit versions of diagnostics from ACON Laboratories and iHealth are being illegally imported to and sold in the US, the agency says. The alert also tells consumers how to spot counterfeit tests.
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News We’re Watching: Disease X Act, Abiomed Recall, TAVR AI Cleared
This week, the bipartisan Disease X Act for pandemic preparedness was introduced in the US House of Representatives; Abiomed Impella pumps were the subject of a class I recall; Dasi Simulations and Endologix landed FDA clearances; and the FDA warned against the use of Getinge/Maquet Oxygenators.
FDA Tweaks Q-Sub Meeting Guidance
The revised guidance document clarifies the Q-submission meeting process, alternate ways sponsors may obtain FDA feedback, and more.