Upcoming Meetings: FDA design control meeting
This article was originally published in The Gray Sheet
FDA design control meeting: Open public meeting to provide a "mid-course" assessment of the agency's design control inspection program will take place at 8:30 a.m. on Feb. 2 at the National Institutes of Health's Natcher Auditorium in Bethesda, Maryland. FDA will present results of its analysis of Design Control Inspectional Strategy Reports gathered during the first six months of the one-year "transition" period preceding enforcement of the quality system regulation's design control requirements on June 1, 1998. The agency also will seek input from device industry reps and other interested parties on topics such as the adequacy of guidance for industry or field investigators...
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