US FDA has given the device industry its biggest peek to date into how it plans to organize its Office of Product Evaluation and Quality (OPEQ) – the mammoth new bureau that will gobble up the duties of a handful of current, distinct offices that handle pre-market, compliance, enforcement and post-market surveillance activities.
Sometime this year, the Office of Compliance (OC), the Office of Surveillance and Biometrics (OSB), and the Office of Device Evaluation (ODE) – all found within FDA's Center for Devices...