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Class I Recalls Surge To Highest Point Ever; FDA Not Sure Why

This article was originally published in The Silver Sheet

Executive Summary

The number of high-risk Class I medical device recalls skyrocketed to its highest point ever last year, leaving FDA officials to ponder what could have caused the dramatic upswing.

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CDRH Terminating High-Risk Device Recalls Faster As Class I’s Increase In 2012

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.

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

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.

Editor’s Picks – Three Notable ‘Silver Sheet’ Stories From 2011

Top stories of 2011. “Silver Sheet” readers were most interested in recalls, an FDA plan to boost device quality and process validation tips.

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