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FDAnews Device Daily Bulletin
Oct. 22, 2012 | Vol. 9 No. 207
Study Finds FDA, CMS Regularly Miss Mandatory Review Timelines
The FDA and Centers for Medicare and Medicaid Services (CMS) continue to struggle — and often fail — to meet statutory deadlines for approving Class III devices and issuing national coverage decisions (NCD), according to a paper in the October issue of Health Affairs that looked at median approval times since the mid-1990s.
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