The U.S. Food and Drug Administration and CMS have launched a "parallel review" pilot program for concurrent review of medical devices for FDA approval and Medicare coverage, according to an FDA release.
Often, device sponsors focus solely on obtaining FDA approval, only to find that Medicare coverage is not automatically forthcoming. Both agencies rely on clinical data in reaching their decisions, and while the two agencies have distinctly different regulatory responsibilities, parallel review can reduce time between FDA approval and Medicare national coverage determinations.
The FDA and CMS, which will begin accepting submissions today, issued procedures for voluntary participation and guiding principles that the agencies will follow during product review. The pilot program will last for up to two years with the possibility for extension. The pilot program will accept no more than three to five submissions per year and is only available for qualifying new medical device technologies. .
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Often, device sponsors focus solely on obtaining FDA approval, only to find that Medicare coverage is not automatically forthcoming. Both agencies rely on clinical data in reaching their decisions, and while the two agencies have distinctly different regulatory responsibilities, parallel review can reduce time between FDA approval and Medicare national coverage determinations.
The FDA and CMS, which will begin accepting submissions today, issued procedures for voluntary participation and guiding principles that the agencies will follow during product review. The pilot program will last for up to two years with the possibility for extension. The pilot program will accept no more than three to five submissions per year and is only available for qualifying new medical device technologies. .
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