Medical device makers can now have have their devices simultaneously evaluated by FDA and CMS, allowing them to know at the same time whether their devices will be approved and covered by Medicare. 

A pilot program, run jointly by FDA and CMS, will begin accepting submissions from sponsors immediately. It is designed to simplify the process for obtaining device approval and receiving Medicare coverage, according to an FDA news release. The program will review up to five products per year, will run for at least two years, and "will focus on innovative technologies that can benefit from the efficiencies of parallel review," according to the release. 

“The pilot program will help the FDA and CMS streamline the parallel review process so that it works efficiently for expedient patient access to safe and effective medical devices,” Jeffrey Shuren, director of CDRH, said in the release.

The program is meant to prevent device makers from discovering that their products will not receive coverage after they've already gone through FDA's approval process. A notice published in the Federal Register includes more details, such as when sponsors will be able to opt out of the voluntary program.

— Thomas Blair