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FDA DEVICE APPLICATION SECONDARY REVIEW LEVELS TO BE REDUCED

This article was originally published in The Gray Sheet

Executive Summary

FDA DEVICE APPLICATION SECONDARY REVIEW LEVELS TO BE REDUCED by "about one half for most submissions," FDA Office of Device Evaluation Acting Director Susan Alpert explained in a March 22 speech at the Health Industry Manufacturers Association annual meeting. Noting that there currently can be "as many as four or five scientific and administrative" evaluations after a primary reviewer finishes work on an application, Alpert said that ODE believes that "for many applications, a single secondary scientific review and an appropriate overall administrative review should be sufficient" to ensure that the primary review was based on "good" science and that office policies were appropriately applied.
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