FDA, CMS Launch Review to Approve Devices for Market, Medicare Coverage

The Food and Drug Administration and the Centers for Medicare & Medicaid Services announced Oct. 7 the launch of a pilot program for parallel review of medical devices for FDA approval and Medicare coverage to accelerate patient access to innovative technologies.

FDA and CMS said they started accepting submissions Oct. 7. FDA and CMS also issued procedures for voluntary participation and guiding principles that the agencies will follow during reviews. The agencies said they anticipate parallel reviews will facilitate the development of innovative new products and increase the efficiency of review processes for both agencies.

The pilot program is voluntary ...