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Medtronic will pay $4.4 million to settle a lawsuit accusing the company of illegally selling Asian-made devices to the U.S. military, Minnesota U.S. Attorney Andrew Luger announced. Read More
The U.S. FDA issued a final rule today placing urethral inserts with pumps to facilitate bladder drainage in Class II with special controls, including biocompatibility testing. Read More
New guidance from the U.S. FDA’s medical devices center aims to help manufacturers get the most benefit from meetings with agency advisory committees by explaining the uses of committee meetings and steps firms can take to prepare. Read More
By 2020, the U.S. FDA will update criteria on antibiotic susceptibility testing devices use to guide appropriate antibacterial drug treatment, under an action plan released by the White House on March 27. Read More
Devicemakers can help to facilitate facility inspections — and improve their inspection experience — by engaging in constructive conversations with agency investigators, a U.S. FDA official says. Read More
Manufacturers of general wellness products wondering how the U.S. FDA might regulate their goods should check how the agency deals with similar devices, an attorney says. Read More
The U.S. FDA should finalize guidance documents on premarket and postmarket data collection, the proposed laboratory-developed tests framework and adverse event reporting, and biocompatibility standards before attacking other priorities, AdvaMed says. Read More