The U.S. Food and Drug Administration and CMS announced an extension on their joint Parallel Review pilot program, according to a Regulatory Focus report.
Launched in October 2011, the Parallel Review program enabled the FDA and CMS to review products simultaneously, as the FDA's device review time and CMS' review to determine if it will to pay for a device are traditionally separate processes. Allowing for concurrent review by the two agencies will ideally shorten the overall review timeline and help new devices integrate into the market more quickly.
The extended, tentative end date for the Parallel Review program is Dec. 18, 2015.
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