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CDRH has unveiled a new dataset to help improve chemical characterization methods for biocompatibility of medical devices as part of its efforts to reduce the burden of premarket processes and increase the consistency and transparency of biocompatibility assessment methods. Read More
The Abbott/Thoratec recall of HeartMate II and HeartMate 3 left ventricular assist system (LVAS) has been deemed Class I, the most serious type of recall, by the FDA. Read More
Of the $341 million increase in funding requested for the FDA in President Biden’s FY 2025 budget proposal, $114 million is needed to fund FDA employees’ 5 percent inflation pay increases for both this year and next, according to the agency’s chief financial officer (CFO). Read More
Less than a month after issuing warning letters to a China-based manufacturer of plastic syringes for various quality and branding violations, the FDA is suggesting U.S. providers and consumers avoid the products altogether. Read More
The FDA is hamstrung from truly mitigating impending drug supply shortages because the agency can’t get a consistently transparent view into drug manufacturers’ operations, FDA Commissioner Robert Califf told the House Committee on Oversight and Accountability during a nearly five-hour hearing on Thursday. Read More
A general sampling of comments received on the RFI do not reflect overwhelming support for the agency to regulate laboratory developed tests. Read More
Three industry groups responding to a Senate committee’s March 14 RFI distributed to stakeholders showed no support for the FDA’s plan to regulate laboratory developed tests. Read More