In 2011, the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) announced a pilot program for concurrent review of certain FDA premarket review submissions for medical devices and CMS national coverage determinations (NCD). The agencies explained that the goal of the pilot program is to “facilitate the development of innovative products and shorten the time it takes to bring these important products to patients.” The agencies announced that they would provide a parallel review for up to five innovative devices per year.
To qualify for the parallel review pilot, a medical device must meet one of the following criteria:
- It must be a new technology for which the sponsor/requester has an approved investigational device exemption application (IDE) or has had sufficient interaction with FDA through the pre-IDE process (now known as the pre-submission process);
- It must be a new technology that would require an original or supplemental application for premarket approval (PMA) or a petition for de novo review; or
- It must be a new technology that falls within the scope of a Part A or Part B Medicare benefit category and are not subject to an NCD.
Last month, Medtronic announced that its hypertension treatment device called Symplicity would undergo the parallel review. On its website, the company noted that the device will provide a renal denervation system for treating drug-resistant hypertension. The company is currently conducting a randomized, controlled trial of renal denervation in the U.S., scheduled to be complete by summer 2013.
The announcement by Medtronic is significant, as it is one of the first companies to participate in the pilot program. Some experts have speculated that the program has been underutilized because companies are hesitant to seek a national coverage determination from Medicare, rather than go the safer route and collect enough local coverage decisions to qualify for Medicare coverage. Medtronic’s experience with the new process may be instructive for medical device companies currently sitting on the sidelines.