FDA Issues SOP Aimed at Standardizing Data Requirements for Premarket Submissions

Nov 28, 2011   

On November 9, 2011, the U.S. Food and Drug Administration (FDA) published “SOP: Decision Authority for Additional or Changed Data Needs for Premarket Submissions.” The document sets forth limitations to the data requirements that agency reviewers may request when reviewing various types of premarket submissions for medical devices. Found here, the document details how reviewers will be limited in the information they request by requiring managements approval, or “concurrence,” in order to seek new or additional data from those seeking agency review.

Prior to the SOP, there was no written policy in place serving to limit reviewers data requests. Thus, device sponsors often found data requests onerous and irrelevant to the safety and efficacy of medical devices. Hopefully, limitations to such data requests will benefit device sponsors by increasing the predictability and efficiency of the premarket review process.

For more information regarding the FDA premarket review process, contact us at contact@fidjlaw.com.