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Firms can expect more Section 522 post-market studies

This article was originally published in The Silver Sheet

Executive Summary

FDA says it will more frequently use its authority to mandate so-called Section 522 post-market studies when companies fail to meet their original post-approval study requirements. Under Section 522 of the Food, Drug and Cosmetic Act, the agency can require a firm to conduct post-market studies for Class II and Class III products that are life-sustaining or life-supporting; are implanted in the body for more than a year; have significant use in pediatric populations; or whose failure would likely lead to serious health consequences. Danica Marinac-Dabic, head of the division of epidemiology in CDRH's Office of Surveillance and Biometrics, says noncompliant companies can expect to see more Section 522 post-market studies imposed on them in the future. An FDA order for a Section 522 study carries substantial force, Marinac-Dabic notes. Unlike PMA post-approval studies, failure to complete a 522 study constitutes device misbranding and can result in civil money penalties, product seizure or prosecution
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