FDA, CMS plan 'parallel review' pilot for devices

The Food and Drug Administration and the CMS said they will launch a pilot program that will concurrently review medical devices in an effort to reduce time between FDA approvals and Medicare coverage determinations.

The two-year “parallel review” pilot program, announced Oct. 7, is voluntary, according to an FDA news release. It will accept up to five submissions a year.

Candidates for the program include technologies that have had sufficient pre-investigational device exemption interaction with FDA or an approved IDE application; technologies requiring a premarket approval or de novo review; and technologies that fall under the Part A or Part B Medicare benefit category and are not subject to a national coverage decision.

“The parallel review program has the potential to increase patient access to innovative devices that improve clinical outcomes,” Dr. Patrick Conway, CMS chief medical officer, said in the news release. “Our goal is to reduce regulatory burden and improve patient outcomes.”

The agencies had initially filed a public notice about the parallel review pilot program in September 2010.

The Federal Register notice states (PDF) that the pilot program may be used to inform the development of similar parallel review programs for drugs and biological products.