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PMA filing review procedures to be clarified via "blue book" changes, ODE's Alpert says.

This article was originally published in The Gray Sheet

Executive Summary

PMA FILING REVIEW CONSISTENCY TO BE IMPROVED through training and revisions to FDA's "blue book" memo on filing procedures for premarket approval applications, Susan Alpert, director of the Office of Device Evaluation in FDA's Center for Devices and Radiological Health, said Nov. 8 at a meeting on in vitro diagnostics held by the Health Industry Manufacturers Association in Arlington, Virginia. Noting the agency's effort to "retrain" reviewers "on how to file" PMAs, Alpert said ODE is "reassessing what our blue book memorandum, our SOP, says about filing."
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