Two Tracks, One Train? CMS And FDA Cooperation

Law360, New York (September 23, 2010, 4:15 PM EDT) -- On Friday, Sept. 17, 2010, the U.S. Department of Health and Human Services (HHS) released notice of its intention to consider a parallel regulatory and reimbursement review process that could result in simultaneous marketing clearance from the U.S. Food and Drug Administration and Medicare national coverage for new medical products.

Public comments are due by Dec. 16, 2010. The notice also announces the intent to create a pilot program for parallel review of medical devices once the agencies have reviewed comments submitted.

A parallel review process...
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