US Medical Device Manufacturers Association (MDMA) briefs court on 510(k) process
This article was originally published in Clinica
The US Medical Device Manufacturers Association has gone to court to ensure that judges understand the 510(k) process. The US Court of Appeals considered, in Reeves v AcroMed, that a "not substantially equivalent" finding was substantive evidence that a device was unsafe in a product liability action.
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