CDRH And Industry Action Spurs Largest Annual Device Recall Count In FDA History
This article was originally published in The Silver Sheet
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.
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As the number of class I recalls climbed to a historic high in 2012, CDRH was already taking action to more quickly terminate such high-risk recalls. The device center beefed up its class I recall close-out process by developing a template to standardize terminations and ensure that recalls were appropriately addressed by manufacturers. “What we’re looking to do is to move beyond just removing the recalled device from the shelf,” CDRH official Ann Ferriter said. Officials at device firms Philips Medical Systems and Cordis sense that FDA has become more stringent, requiring nearly 100 percent of product pulled from the market before declaring a recall closed. Meanwhile, CDRH is tackling recall-related provisions outlined in the FDA Safety and Innovation Act, and an ex-FDA official explains why he believes the number of overall recalls jumped 9 percent in 2012.
Behind The Scenes At FDA: Former CDRH Compliance Director Talks Device Recalls
Tim Ulatowski, the former director of CDRH’s Office of Compliance, is concerned about the overall volume of medical devices being recalled, as well as the number of high-risk class I recalls reported by manufacturers. “Things appear to be out of control,” Ulatowski says. In an interview with “The Silver Sheet,” he opened up about his handling of class I recalls when he was in charge of the compliance office and the large recall backlog that developed during his tenure, among other topics.
News In Brief
Senators want to know why it’s taking so long for the Office of Management and Budget to release FDA’s proposed UDI rule; CDRH’s 2013 budget increase would come from industry.