FDA's Updated Draft Animal Testing Guidance Clarifies Its Scope
The US FDA’s guidance document on animal testing for medical devices clarifies the scope of a document issued in 2016.
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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.