QUALITY SYSTEM APPROACH TO CLINICAL TRIALS CAN ENHANCE DEVICE MARKETABILITY

Device firms can avoid regulatory violations and move their products into the market sooner by building quality systems (QSs) into their clinical trials, according to an FDA official.

Firms should integrate QSs into their clinical trial processes to correct recurring problems before they jeopardize premarket approval (PMA) submissions, Michael Marcarelli, director of the Division of Bioresearch Monitoring (BIMO) in the Office of Compliance at CDRH, told attendees last month at an FDAnews inspections summit.

"We only see firms come up with a QS process when they get into trouble," Marcarelli said. "They make changes after two years of having a product on hold."

Failing to address QS issues can "compromise the quality and poolability of your data and could derail your [PMA] application," Marcarelli said. The best approach for firms is to apply clinical trial QSs to their highest-risk products because implementing a QS is expensive, he said. (http://www.fdanews.com/ddl/33_50/)