Parallel Review Pilot for Innovative Devices Launched by FDA and CMS

A parallel review pilot program newly deployed by the US FDA and the Centers for Medicare & Medicaid Services (CMS) could expedite the review process for some cutting-edge devices and make Medicare reimbursement requirements more transparent.

The program allows concurrent review of devices by both FDA and CMS staff, minimizing the time between FDA 510(k) clearance or approval and Medicare coverage decisions. Although FDA and Medicare reviews of medical devices are not identical, both agencies use clinical data to inform their decisions.

Devices qualifying for parallel review include:

  • New technologies that have been granted a pre-investigational device exemption (IDE) or approved IDE application designation
  • New technologies that would require either a supplemental application for premarket approval or a de novo petition
  • New technologies falling within Part A or Part B Medicare categories that are not subject to national coverage decisions

The program is slated to last for up to two years, but will accept only three to five submissions per year. Assuming the program’s pilot phase proves successful, the agencies should seriously consider expanding access to the program to a wider variety of medical devices.

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