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Companies should use existing registry data

This article was originally published in The Silver Sheet

Executive Summary

Manufacturers should tap into data from existing device registries to help fulfill post-approval study requirements in a practical way, FDA says. The agency has been devoting significant resources lately to improving its approach to post-market studies required as a condition of approval for many PMA devices. By using existing registries - such as the American College of Cardiology's National Cardiovascular Data Registry - firms can answer questions about the real-world performance of products without starting a new trial from scratch, Danica Marinac-Dabic, epidemiology director in CDRH's Office of Surveillance and Biometrics, said at a Sept. 9-10 public workshop at FDA's White Oak Campus in Silver Spring, Md. The registries also "play a critical role in device surveillance," added Tom Gross, deputy director of post-market science at OSB. However, FDA points out that registries cannot replace prospectively designed observational studies in all cases. The agency requests varying study designs based on "the value and the quality of the pre-market data," Marinac-Dabic said

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