FDA, CMS launch pilot for parallel review of devices

FDA and CMS launched a voluntary pilot program for parallel review of medical devices, which could reduce the time between FDA approvals and CMS National Coverage Determinations (NCDs). The program will not change the review standards at either agency. The two-year program, which may be extended, will accept between three and five submissions per year for devices requiring a PMA and covered under Medicare Parts A and B. The agencies plan to use feedback from the pilot to develop parallel review programs for drugs and biologics (see BioCentury, Oct. 18, 2010). ...