FDA downclassifies cell counters:
This article was originally published in Clinica
Automated differential cell counters are being reclassified by the FDA from class III, high-risk, devices requiring premarket approval, to class II, medium-risk devices. Companies who want to market a device of this sort must consult the agency's special guidance on what is required in a premarket notification or 510(k) for the product, the agency said. The FDA first proposed reclassifying the devices in May 2001, based on the recommendations of its haematology and pathology devices advisory panel.
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