October 7, 2011
On Friday, October 7, 2011, the U.S. Food and Drug Administration (FDA) and Centers for Medicare & Medicaid Services (CMS) launched a “parallel review” pilot program for concurrent review of medical devices for FDA approval and Medicare coverage.
Both the FDA and CMS will begin accepting submissions October 7th on issued procedures for voluntary participation and guiding principles that the agencies will follow during product review. They anticipate that parallel review will facilitate the development of innovative new products and increase the efficiency of the review process for both agencies.
The pilot program will last for two years with the possibility for extension and the program will accept no more than three to five submissions per year.
For more information:
FDA News Release - http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm274833.htm
FDA-CMS Premarket Review - http://www.fda.gov/parallel-review