CDRH And Industry Action Spurs Largest Annual Device Recall Count In FDA History

By Shawn M. Schmitt / Email the Author / “The Silver Sheet” February 2012, Vol. 16, No. 2
Word Count: 4111 / Article # 09120215009

Executive Summary

Device recalls increased 33 percent in 2011 because of FDA’s work to reduce a backlog of unclassified recalls, manufacturer concern about nonconforming products and the agency’s sharp focus on radiological device safety, among other explanations. “The elimination of the recall backlog in ORA and the center, as well as enhanced industry reporting, were big factors across all FDA-regulated products,” said Ann Ferriter, director of the Division of Risk Management Operations in CDRH’s Office of Compliance. And the center is continuing to improve: In the first quarter of FY 2012, it achieved an 80 percent on-time classification rate thanks to work by its “Recall Process Improvement Project,” which is due to wrap up by Oct. 31. In related news, Congress may consider legislation requiring FDA to establish a program to routinely assess recall information, and ORA is looking to beef up its recall audit check process.