FDA, CMS team up for medical device review pilot

The FDA and the Centers for Medicare & Medicaid Services (CMS) have launched a pilot program to conduct parallel reviews of medical devices for concurrent FDA approval and Medicare coverage.

The agencies began accepting submissions Oct. 7, and issued procedures for voluntary participation and guiding principles that they will follow during product review.

“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,” said Jeffrey E. Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, in a statement.

Because each agency requires clinical data, but has different regulatory responsibilities, they anticipate the parallel review can reduce time between FDA approval and CMS coverage determinations.

The pilot program will last for two years with the possibility for extension and will focus on innovative technologies that can benefit from the efficiencies of the parallel review. The program will accept no more than five submissions per year.

The agencies listed the following characteristics as appropriate for concurrent FDA and CMS device review:

1. New technologies for which the sponsor/requester has a pre-investigational device exemption (IDE) or an approved IDE application designation.
2. New technologies that would require an original or supplemental application for premarket approval (PMA) or a petition for de novo review.
3. New technologies that fall within the scope of a Part A or Part B Medicare benefit category and are not subject to a national coverage decision.

The agencies intend to use their experience with the pilot program to develop a parallel review program for devices, as well as drugs and biological processes. Click here for more information.