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FDA Looks To New Program To Ease Inspection Burdens For All – But Will Manufacturers Get On Board?

This article was originally published in The Silver Sheet

Executive Summary

A new voluntary FDA program aims to relieve the inspectional load on manufacturers and the agency. Under the program, firms would submit to FDA a recent ISO 13485 audit report, along with other data, to gain a one-year reprieve from agency inspections. FDA will use the reports as part of “a risk-based process for planning, and using FDA resources and inspection resources wisely,” says Kim Trautman, associate director for international affairs in CDRH’s Office of the Center Director. However, two former FDA officials and some manufacturers believe the new program could fail and swirl down the same drain as other little-used FDA inspection initiatives. “Honestly, I don’t know who would participate,” says Elisabeth George of Philips Medical Systems.

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