Concurrent Review of Medical Devices

Despite recent criticims regarding the Food and Drug Administration’s review process for medical devices, the FDA and the Centers for Medicare and Medicaid (CMS) launched a “parallel review” pilot program for concurrent review of medical devices for FDA approval and Medicare coverage.

The pilot program, which is voluntary, will not alter any of the existing and distinct review standards the FDA or CMS currently have in place. Rather, it should facilitate the development of innovative new products and increase the efficiency of the review processes for both agencies. In turn, this will hopefully allow devices to reach consumers more quickly, and reduce the problem with devices that are approved by the FDA but not automatically (or expediently) approved by Medicare for its beneficiaries.  CMS also hopes to work with the FDA to facilitate post-approval study by implementing coverage with evidence development (CED), allowing the Medicare beneficiaries to use the device within the parameters of the post approval study under CED.

The pilot program will last two years (with an opportunity to extend) and will accept no more than four to five submissions a year.  Appropriate candidates for the parallel review pilot are medical devices that meet one of the following criteria:

  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 (NCD).