Regulatory News

Barriers to FDA and CMS Parallel Reviews: Fear and Bandwidth, Shuren Says

Medical device companies should want to streamline the process of getting their products reviewed simultaneously by the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) and Centers for Medicare and Medicaid Services (CMS) - so why aren’t they?

Jeff Shuren, director of CDRH late Monday told attendees of JP Morgan’s annual conference that he thinks fear and a limited amount of CMS staff are two reasons that the parallel review program has not taken off as well as hoped.

"What you’re seeing publicly is a lot less than what’s actually happening," Shuren said, calling on companies to engage with FDA and CMS "early and often."

The comments come as just two products have successfully navigated an FDA and CMS parallel review and as an FDA spokesperson told Focus that the agency has received about 60 inquiries from device makers about the parallel review program and received 26 applications to participate.

As far his two reasons for the slow movement in the parallel review program helping companies, Shuren noted that companies can be afraid about what might be said in such preliminary discussions and that "CMS has much more limited bandwidth [than FDA]  to do this and do this well."

Tamara Syrek Jensen, director of the coverage and analysis group at CMS tried to reassure companies that they can seek out advice without making anything official.

"There’s an MOU [memorandum of understanding] between FDA and CMS – if anyone wants to come talk to both of the agencies, they can do that now," Jensen said. "Start the conversation, give us a call."