FDAnews Device Daily Bulletin

EVOLVING FDA INSPECTION PROCESS WILL PLACE GREATER PRESSURE ON MANAGERS, OFFICIAL SAYS

June 27, 2006
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Managers at device and diagnostics manufacturing facilities can expect to bear the brunt of accountability for lapses in their quality systems (QS), a compliance official with the FDA's Center for Devices and Radiological Health (CDRH) said at a recent industry conference.

In conducting inspections, "There is going to be some new scrutiny, particularly on management," Casper Uldriks, special assistant to the director of compliance at CDRH, said June 20 at the Medical Device and Diagnostics Marketing Compliance Congress in Washington, D.C.

As part of an emerging new approach, the agency is planning to ramp up its review of companies' management systems. It's not just what managers say they're going to do -- it's what they do that matters, said Uldriks. "We want results."

"If people aren't making the right decisions or aren't making decisions at all," it can have a negative ripple effect on the whole system, he noted.

To enhance its oversight of management processes, CDRH is placing "a new focus on the entire corporation" that will include multisite inspections affecting both premarket and postmarket devices, as well as exports and imports, Uldriks noted.

Uldriks wondered aloud whether executives and managers are often out of the loop in terms of responding to adverse events and other lapses in the QS. Executives and managers need to work together, Uldriks said. "If they are isolated from each other, [the QS] won't work."

(http://www.fdanews.com/ddl/33_26/)