Parallel FDA and CMS review of new technologies can save manufacturers research costs and reduce the time between FDA approval and national Medicare coverage of a new technology, according to at least one of the companies that has participated in the program.
The two agencies formally launched a pilot program for parallel review in 2011, opening up a collaborative effort that allows CMS to begin considering a national Medicare coverage policy for select new technologies as FDA is reviewing the safety and efficacy of a device for regulatory approval. (See Also see "Calling All Innovators: FDA And CMS Seek Candidates For Parallel Review Pilot" - Medtech Insight, 17 October, 2011.
