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

December 12, 2014 by Brian Johnson

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.

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

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.

Edwards CEO Mussallem hopes FDA to accelerate approvals of medical devices

December 9, 2014 by MassDevice

Michael Mussallem, CEO, Edwards Lifesciences says FDA regulators are looking to speed up approvals for medical devices

Edwards CEO talks innovation and regulation on Capitol Hill

(Reuters) - U.S. health regulators appear open to speeding up approvals of medical devices that currently often reach European markets three to five years ahead of being cleared in the United States, the chief executive officer of Edwards Lifesciences (NYSE:EW) said.

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