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The FDA’s proposed framework for health IT regulation, due to Congress by January, will likely focus heavily on adverse event reporting and data collection, an attorney who has worked with the agency on developing the framework predicts. Read More
Innovations in diagnostic medicine have allowed rapid progress against malaria, tuberculosis and other infectious diseases, and enabled testing of patients in remote, underserved regions of the world, experts from the Centers for Disease Control and Prevention say. Read More
A proposed policy that would allow hospitals to set their own maintenance schedules for medical equipment could pose a significant risk to users of imaging and radiological devices, a coalition of medical societies says. Read More
At the close of a comment period on the quality management systems reporting burden for devicemakers, the FDA received just one reply requesting a few clarifications. Read More
A bill to regulate medical apps according to risk continues to spark debate, with supporters saying it is needed to protect innovation and detractors saying it is premature. Read More
San Up, a Buenos Aires maker of piston and ultrasonic nebulizers, was warned by the FDA after cleaning shortfalls and other good manufacturing practice slip-ups. Read More
The FDA’s device center needs to improve consistency in decisionmaking during premarket reviews and ensure all employees are up to speed on its review software systems, Booz Allen Hamilton says in a preliminary set of priority recommendations on the review process. Read More
Industry can expect an international effort to revise and update software device standards over the next few years, CDRH Director Jeffrey Shuren says. Read More
Industry got two wins in Tuesday’s bipartisan budget deal, which recommends the repeal of the 2.3 percent medical device excise tax and removes the threat of sequestration hanging over fiscal 2014 and 2015 FDA user fees. Read More