November 1, 2011

FDA, CMS Launch Pilot Program for Voluntary Parallel Review of Medical Devices

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The U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) have launched a two-year, “parallel review” pilot program for concurrent review of medical devices for FDA approval and Medicare coverage.

The FDA and CMS, which began accepting submissions October 11, issued procedures for voluntary participation and guiding principles that the agencies will follow during product review. According to an FDA press release, the two agencies anticipate that parallel review will facilitate the development of new products and increase the efficiency of the review processes for both agencies. The pilot program, announced in a Federal Register notice, will not change the existing separate and distinct review standards for FDA device approval and CMS coverage determination.

During its pilot phase, the agencies will offer to perform parallel review for up to five devices per 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. Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.
  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 determination (NCD).

“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 Shuren, MD, director of the FDA’s Center for Devices and Radiological Health.

Often, device sponsors focus solely on obtaining FDA approval, only to find that Medicare coverage is not automatically forthcoming, according to the press release. Both agencies rely on clinical data in reaching their decisions, and while the two agencies have distinctly different regulatory responsibilities, parallel review can reduce time between FDA approval and Medicare NCDs.

The Federal Register notice also outlines the agencies’ commitment to ensuring that submitted data is confidential and highlights when sponsors can opt-out of the parallel review program.

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