divendres, 12 de desembre del 2014

FDA honcho Maisel: Study could downgrade some high-risk devices




Dr. Bill Maisel, deputy director for science at the FDA's Center for Devices & Radiological Health, tells medtech execs the agency is halfway through its review of the PMA process, which could result in some devices being removed from the high-risk category.






The FDA is about halfway through a retrospective study of its pre-market approval program, a review that could result in some devices being removed from the highest-risk category, according to Dr. Bill Maisel, deputy director for science at the FDA's Center for Devices & Radiological Health.




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