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Uncertainty about reimbursement now trumps FDA approval as the major impediment to private funding for new medical technologies, a venture capitalist told lawmakers during a Wednesday hearing on economic and regulatory incentives to encourage device development. Read More
The FDA’s draft guidance on distinguishing recalls from product enhancements contradicts current regulations, creating “a new sort of burden for industry,” an attorney says. Read More
CoHiTech, a Barcelona, Spain, manufacturer of tampons and menstrual pads received an FDA warning letter for in-process testing procedures and other quality issues. Read More
Manufacturers will get more guidance on how to communicate off-label uses by the end of the year, the FDA said in a June 6 response to two citizen petitions. Read More
Results from Team-NB’s third member survey show the number of ISO 13485 certificates issued to devicemakers last year declined by 10 percent. 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