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Manufacturers of in vitro diagnostics and low-risk medical devices could have an easier time registering their products in Brazil, thanks to a pair of resolutions proposed by Anvisa. Read More
CDRH is expecting a large number of devicemakers to take advantage of the Expedited Access PMA program proposed in draft guidance in April, center Director Jeffrey Shuren said during a Thursday webinar hosted by the Pew Charitable Trusts. Read More
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