Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.
The FDA’s recent approval of a gene-based diagnostic to improve blood matching before transfusions is just the first step for a technology that could vastly improve patient care, a panel of experts said recently. Read More
The FDA’s Circulatory Systems Devices Panel overcame concerns about data disparities and limited follow-up to unanimously recommend approval of a first-in-class catheter to treat peripheral artery disease in the leg. Read More
Bowing to industry pressure, the FDA said Thursday it is withdrawing a rule to move cranial electrotherapy stimulators to Class III and will continue to regulate the devices in Class II with special controls. Read More