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DEVICE WARNING LETTER DECLINE CONTINUES UNDER PILOT PROGRAM

This article was originally published in The Silver Sheet

Executive Summary

FDA MEDICAL DEVICE INSPECTION INITIATIVES continue to foster greater interaction between manufacturers and the agency. The agency's warning letter pilot and "customer satisfaction" survey program are encouraging post-inspectional dialogue while the recently launched QSIT device auditing approach provides for increased pre-inspection communications. As both device center and field personnel face additional duties due to recent device premarket initiatives, FDA's Office of Regional Operations is exploring ways to enhance its productivity and streamline its processes, including adoption of a "quality management system" WARNING LETTERS: QS reg violations at Alaris Medical require quarterly certifications of corrective actions by an outside consultant; Synthes cited for inadequate corrective action and final acceptance procedures
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