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DESIGN CONTROLS CITED IN HALF OF ALL QUALITY SYSTEM WARNING LETTERS IN 2005, BUT FDA SAYS FIRMS HAVE MADE GREAT PROGRESS IN PAST 10 YEARS

This article was originally published in The Silver Sheet

Executive Summary

NEARLY TEN YEARS AFTER FDA REQUIRED DESIGN CONTROLS by way of the Quality System Regulation, statistics show that some manufacturers still are not meeting the requirements, with half of all quality system warning letters issued in 2005 containing some sort of design control violation. However, experts agree that companies’ attitudes toward design controls have come a long way since the regulation was published in 1996. CDRH Quality Systems Expert Kim Trautman says the agency still believes strongly in the flexibility built into the design control requirements, but notes that this flexibility also can lead to trouble for firms that don’t play by the rules. "We’re giving manufacturers a rope," she says. "They can either use that rope for good ... or they can hang themselves with that rope when they don’t use it wisely"... 2006 COULD BRING SOME IMPORTANT CHANGES to the device industry, including stricter postmarket surveillance and an intensified focus on risk management, experts predict...
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