A number of individuals are charged and sentenced for their involvement in durable medical equipment and related telemarketing fraud; the FDA sends its proposed rule regarding laboratory developed tests (LDTs) to the White House Office of Information and Regulatory Affairs (OIRA) for review; a regulatory affairs specialist pleads guilty to forging false letters from the FDA purporting to show that the FDA had granted clearance to sell two different medical devices; and a manufacturer of hemodialysis machines receives a warning letter See more +
A number of individuals are charged and sentenced for their involvement in durable medical equipment and related telemarketing fraud; the FDA sends its proposed rule regarding laboratory developed tests (LDTs) to the White House Office of Information and Regulatory Affairs (OIRA) for review; a regulatory affairs specialist pleads guilty to forging false letters from the FDA purporting to show that the FDA had granted clearance to sell two different medical devices; and a manufacturer of hemodialysis machines receives a warning letter regarding its failure to submit a 510(k) or PMA to address the addition of water filtration components to its hemodialysis system. See less -
