A prevailing theme in the user fee discussions between the device industry and the U.S. Food and Drug Administration (FDA) has been a concern about review times and unpredictable data requests during the review period.
These concerns are what make the FDA’s release of a new standard operating procedure (SOP) in early November so important. The SOP, “Decision Authority for Additional or Changed Data Needs for Premarket Submissions,” essentially requires that individual reviewers obtain “concurrence from appropriate management…before taking any action” with regard to requesting data that differs from other premarket submissions for the device type or previous communications with a manufacturer.
SOP in Practice
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