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"PMA DAYS" FOR FDA/SPONSOR RESOLUTION OF OUTSTANDING ISSUES ARE ENCOURAGED

This article was originally published in The Gray Sheet

Executive Summary

"PMA DAYS" FOR FDA/SPONSOR RESOLUTION OF OUTSTANDING ISSUES ARE ENCOURAGED in an Office of Device Evaluation "Blue Book" memorandum on closure of premarket approval applications. As part of an effort to ensure efficient and timely review of PMAs, ODE divisions "should consider setting aside specific 'PMA days' during which reviewers and managers will work with PMA applicants to resolve issues necessary to bring closure to these PMAs," the memo says.
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