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Guidances Outline PMA Review Process For Manufacturing, Clinical Sections

This article was originally published in The Silver Sheet

Executive Summary

TWO DRAFT GUIDANCES RELEASED BY FDA provide timetables for the agency’s review of the quality systems and clinical data portions of premarket approval submissions, and also aim to ensure that manufacturers are prepared for PMA pre-approval manufacturing and clinical trial inspections. CDRH Director Tim Ulatowski explains that the guidances will help the center meet time goals set forth in the Medical Device User Fee & Modernization Act. He says the documents "make it clear to center staff and to headquarters and field staff that these goals are important, that there are timeframes that need to be met." Meanwhile, approximately 15% of companies usually aren’t ready for their pre-approval inspections, Ulatowski says, pointing out that the rate has been as high as 50% at various times... GUIDANT’S PROBLEMS RUN DEEPER THAN COMMUNICATION ISSUES, according to Boston Scientific’s CEO, who says it could take up to two years for the company to address underlying design and production problems with Guidant’s ICDs and pacemakers...

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