New Compliance Head Attributes Recall Increase to Market ‘Rush’

In their rush to gain market share, devicemakers may be launching 510(k) devices without addressing some safety concerns, a CDRH official says in explaining an increase in Class I recalls. “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,” Steve Silverman, the new director of compliance at CDRH, said. By spring of this year, the number of Class I device recalls equaled the number reported for all of fiscal 2009.
Devices & Diagnostics Letter