CDRH Official: Recall Increase Tied to Market ‘Rush’

In their rush to gain market share, devicemakers may be launching 510(k) devices without addressing some safety concerns, Steve Silverman, director of compliance at CDRH, says.

“Manufacturers are moving products to market faster than they ought to and are using the marketplace as an environment to work out the bugs in their products,” Silverman said. By spring of this year, the number of Class I device recalls equaled the number for all of fiscal 2009.

When asked why the FDA doesn’t catch problem devices until they’re on the market, Silverman pointed to the agency’s limited ability to perform pre-clearance inspections for 510(k) devices. Silverman also admits his rush theory doesn’t fully account for the increase in Class I recalls since PMA devices make up the majority of the recalls.
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