FDA update October 11, 2011

FDA, CMS launch pilot program for voluntary parallel review of innovative devices

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

The FDA and CMS, which will begin accepting submissions today, issued procedures for voluntary participation and guiding principles that the agencies will follow during product review. The FDA and CMS anticipate that parallel review will facilitate the development of innovative new products and increase the efficiency of the review processes for both agencies.

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

Often, device sponsors focus solely on obtaining FDA approval, only to find that Medicare coverage is not automatically forthcoming. 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 national coverage determinations.

The parallel review program has the potential to increase patient access to innovative devices that improve clinical outcomes

The pilot program, announced in a Federal Register notice posted for advanced viewing today, is voluntary and will not change the existing separate and distinct review standards for FDA device approval and CMS coverage determination. It is only available for qualifying new medical device technologies. 

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. 

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

During its pilot phase, the agencies will offer to perform parallel review for up to five innovative 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.
  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).

Any questions on this FDA guidance please email us at info@mdiconsultants.com and RefCMS and FDA parallel review.

For more information on this guidance you can go to the following link:http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/ucm255678.htm