FDA's Updated Draft Animal Testing Guidance Clarifies Its Scope
Executive Summary
The US FDA’s guidance document on animal testing for medical devices clarifies the scope of a document issued in 2016.
You may also be interested in...
FDA Focuses On Animal Testing, Trial Endpoints In BPH Device Draft Guidance
Draft guidance from the US FDA updates the agency’s recommendations around research to support new devices for the treatment of prostate enlargement.
US FDA Draft Guidance On Medical Device Animal Studies Is 'Confusing', Says Industry
The US Food and Drug Administration's recent draft guidance on how medical device companies should design and report the results of animal studies is 'confusing', says medtech industry association AdvaMed1,2.
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.