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...