CDRH Following Up More Actively On Complaints Against Device Manufacturers

By Shawn M. Schmitt / Email the Author / “The Silver Sheet” January 2012, Vol. 16, No. 1
Word Count: 3409 / Article # 09120111006

Executive Summary

FDA’s device center is using a new system to triage complaints filed against companies, with the aim of focusing on those representing the highest risk to patient safety. The system, put into use in December, “helps us eliminate complaints that are not significant enough to take action on and it helps us be more consistent with the handling of complaints,” said Ann Ferriter, director for the Division of Risk Management Operations in CDRH’s Office of Compliance. Firms often file trade complaints accusing competitors of selling low-quality products or failing to file MDRs. Although FDA does not notify a company when a complaint has been lodged against it, the firm can pick up on clues.