FDA, CMS launch parallel review pilot for medical devices

The Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) last month launched a parallel review pilot program for concurrent review of new medical devices for FDA approval and Medicare coverage. The voluntary program will focus on innovative technologies that can benefit from the efficiencies of parallel review and accept up to five submissions per year. "The parallel review program has the potential to increase patient access to innovative devices that improve clinical outcomes," says CMS Chief Medical Officer Patrick Conway, M.D. "Our goal is to reduce regulatory burden and improve patient outcomes."

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