CDRH Terminating High-Risk Device Recalls Faster As Class I’s Increase In 2012
• By Shawn M. Schmitt
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.
FDA’s device center has significantly sped up the process for terminating class I product recalls at a time when the number of those high-risk corrections and removals continues to grow.
CDRH terminates a class I recall after it determines that a manufacturer’s corrective actions were sufficient to prevent a recurrence of problems that led to a recall.
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