More dialogue on IVDMIAs

FDA needs more input from stakeholders before finalizing any policy on in vitro diagnostic multivariate index assays, AdvaMed says in March 5 comments on the agency's proposed guidance (1"The Gray Sheet" Feb. 12, 2007, p. 6). Among other unresolved questions, "it is still unclear what postmarket regulatory requirements will be applied to IVDMIAs," AdvaMed says. The trade group recommends that FDA either clarify the guidance or withdraw it and promulgate a rule instead. Meanwhile, the agency should "allow the continued marketing of existing IVDMIAs that have not demonstrated measurable risk to public health," AdvaMed argues...