FDA evaluation of MDR denominator data pilot will include industry input, OSB's Kessler says.
This article was originally published in The Gray Sheet
MDR DENOMINATOR DATA PILOT EVALUATION BY FDA WILL INCLUDE INDUSTRY INPUT, Larry Kessler, Director, Office of Surveillance and Biometrics, said Sept. 10 at the Regulatory Affairs Professionals Society annual meeting in Washington, D.C. An upcoming Federal Register notice will identify the devices FDA has selected for the pilot, and also will explain "how we're going to go about doing the study and evaluating it." FDA is "going to solicit" industry comments on how the pilot should be evaluated, Kessler said.
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