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FDA Surprised By Device Manufacturer's Quick Consent Decree Turnaround

This article was originally published in The Silver Sheet

Executive Summary

WHEN A DEVICE MANUFACTURER ENTERS INTO A CONSENT DECREE with FDA, it often takes years to solve its quality systems problems and obtain clearance to begin selling its devices again. However, Custom Ultrasonics, a Pennsylvania maker of endoscope disinfection systems, worked through its consent decree in less than four months. “It's the fastest I've seen around here,” CDRH Compliance Director Tim Ulatowski says. Ulatowski says FDA will consider making more use of consent decrees rather than issuing multiple warning letters to companies. Legal experts discuss how firms should handle a consent decre





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