FDA reviewers' requests for more premarket data must be clearly explained, Burlington says.
This article was originally published in The Gray Sheet
Executive Summary
FDA DEVICE REVIEWERS' REASONS FOR ADDITIONAL PREMARKET DATA REQUESTS should be clearly explained to sponsors of premarket submissions, Bruce Burlington, director of FDA's Center for Devices and Radiological Health, says in a recent memo to premarket review staff. The device center must not only "clearly understand why we want more data and what it is we want," Burlington says, but must also "clearly and explicitly convey" to the sponsor "what we are looking for and why we want it."