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Despite Only Two Parallel Review Success Stories, CMS Touts Better Coordination

While only two devices have received approval and a national coverage determination through US FDA/CMS' parallel review program, a top CMS official says industry needs to look beyond just the numbers. Instead, she says the parallel review program is part of a sea-change that has allowed for better communication between CMS, FDA and sponsors.

FDA CMS

Since the medical device parallel review pilot program took effect in 2011, only two participating products have been green-lighted by US FDA and the Centers for Medicare and Medicaid Services. But that alone however shouldn't be the metric to judge its success Tamara Syrek Jensen, director of the evidence and analysis group at CMS suggests. She argues the program has opened lines of communication for formal and informal talks with the agency that weren't there before.

Speaking at the Medical Device Manufacturers Association annual meeting in Washington, D.C., on May 4, Syrek Jensen told attendees there...

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