A Comprehensive Analysis of Postmarket Surveillance Study Orders: Device Characteristics, Study Statuses, Outcomes, and Potential Contributions.

Our investigation highlighted that postmarket surveillance study orders resulted in the weeding out of many of the subject medical devices. There were little clinical data produced under the program. Timely and transparent feedback from the postmarket studies are critical for informed decisions by patients and medical practitioners and in expediting patient access to innovative or advanced medical devices.