CMS & FDA Propose Parallel Review of Medical Products

OPEN MINDS Weekly News Wire Strategic Health Care News On September 17, 2010, the Centers for Medicare and Medicaid (CMS) and the U.S. Food and Drug Administration (FDA) requested comments on their plans to implement a parallel review process for medical products. This parallel review would overlap CMS coverage determinations and FDA marketing approval to reduce the time between the two processes. The two agencies are in the process of planning a pilot parallel review program for medical devices. The agencies released the proposal in a Federal Register notice to solicit comments on products appropriate for parallel review, how . . .