FDA plans to down-classify a range of products
This article was originally published in Clinica
The US FDA has proposed a number of reclassifications of medical devices into lower-risk categories to speed up approval times. At the request of bioMerieux Vitek, the agency is seeking comment on whether to move fully-automated, short-term incubation cycle antimicrobial susceptibility devices from the highest risk category of Class III to Class II.
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