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Medical devices get parallel review pilot from FDA and CMS

The U.S. Food and Drug Administration and the Centers for Medicare & Medicaid Services have launched a parallel review pilot program that allows medical devices to be reviewed for approval by the FDA and CMS at the same time.

“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, in a statement announcing the launch of the pilot program.

“The parallel review program has the potential to increase patient access to innovative devices that improve clinical outcomes. Our goal is to reduce regulatory burden and improve patient outcomes,” added Patrick Conway, MD, CMS chief medical officer, in the same statement.

The announcement in the Federal Register about the parallel review program said that the program was initiated in part because those creating medical devices often put all their energy into getting FDA approval and then discover that Medicare coverage doesn’t automatically come with FDA approval.

The pilot program is voluntary and doesn’t change existing FDA or CMS review standards. It is open only to qualifying new medical device technologies. The notice in the Federal Register defines appropriate candidates as using new technologies:

• which have had sufficient pre-investigational device exemption (IDE) interaction with the FDA or an approved IDE application
• for which an original or supplemental application for premarket approval (PMA) or petition for de novo review would be required
• that are within the scope of a Part A or Part B Medicare benefit category and are not subject to a national coverage determination

The pilot program is expected to run for two years. It could be terminated early or extended. The FDA and CMS plan on using the pilot program for parallel review of medical devices to develop a similar pilot program for drugs and biological products.

Follow HFN associate editor Stephanie Bouchard on Twitter @SBouchardHFN.