Article perview reprinted from "The Gray Sheet" - August 31, 2009
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 - and this time, the idea might actually stick. Read more...
FDA May Impose More "522" Studies As Post-Approval Enforcement Tool
Article perview reprinted from "The Gray Sheet" - August 31, 2009
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 - and this time, the idea might actually stick.
FDA has authority under two separate sections of the Food, Drug and Cosmetic Act to require companies to conduct post-market studies.
Post-approval studies required as a condition of PMA approval are the most common. But FDA says it will now make more use of its authority to impose another type of post-market surveillance study, particularly for firms that fail to meet their regular post-approval study requirements.
The new strategy is an attempt by the agency to deal with device firms that never complete their PMA post-approval studies.
According to data presented at an Aug. 18 FDA advisory panel meeting, 26 of the 120 ongoing post-approval studies, or more than 20%, are not progressing to FDA's liking.
About 53 of the post-approval studies are progressing adequately, 32 are pending, about seven have a protocol pending and one firm's protocol is overdue, FDA reported.
Danica Marinac-Dabic, head of the division of epidemiology within CDRH's Office of Surveillance and Biometrics, says non-compliant companies can expect to see more Section 522 post-market studies imposed on them in the future.
Section 522 of the FDC Act allows FDA to mandate post-market studies for Class II and 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.
An FDA order for a Section 522 study carries substantial force, Marinac-Dabic noted. Unlike with PMA post-approval studies, failure to complete a 522 study constitutes device misbranding, and can result in civil money penalties, product seizure or prosecution.
In May 2008, responsibility for the Section 522 post-market surveillance program transferred to OSB's epidemiology division.
Under Marinac-Dabic, who has led FDA's efforts to address post-approval study oversight, the division will build the program further.
- Jessica Bylander
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