FDA to Update Standards Program

To better meet devicemakers’ needs, the FDA is updating its consensus standards procedures for 510(k) submissions. Consensus standards in 510(k) submissions, also known as Form 3654, were originally intended to provide a less burdensome approach to satisfying certain requirements for regulatory clearance of medical devices and diagnostics, Carol Herman, director of the FDA’s Medical Devices Standards Program, said during a recent AdvaMed audioconference.
Devices & Diagnostics Letter