US industry asks Congress for help over a move by FDA that could weaken its defence in product liability lawsuits
This article was originally published in Clinica
Executive Summary
The medical technology industry in the US wants Congress to hold a hearing to look into a proposed rule by the FDA that would greatly limit companies' ability to cite agency approval of a premarketing approval application (PMA) or an investigational device exemption (IDE) as defence against a product liability lawsuit.