October 12, 2010
Exponent Medical Device Seminar
Changes in the 510(k) Process: A Look into the Crystal Ball
Wednesday, November 3, 2010
Many changes are expected to take place in the FDA's 510(k) processes including a possible re-organization of the entire agency. Of significant interest to medical device developers is the intended overhaul of the 510(k) process, which has led to FDA conducting its own internal review in addition to an FDA-commissioned report from the Institute of Medicine. Further, the FDA and the Centers for Medicare and Medicaid Services (CMS) are considering establishing an optional process for parallel, overlapping evaluations of premarket FDA-regulated medical devices. 510(k) reform is also likely to lead to increased requirements for preclinical and clinical testing of new devices as well as to more scrutiny by the FDA of innovative devices. How will these changes impact current medical device developers and how can they prepare? Click here for more information and registration.