Does FDA “approval” mean a product is safe?
October 31st, 2011 admin
by: Christina Kazepis, Esq. Through the 510K clearance process, a host of medical devices considered to be “moderate risk” or Class II devices have been implanted in patients without the FDA investigating or approving the safety of these products. The 510K clearance process does not require that medical devices undergo clinical trials involving humans before [...]
