Guidance on submitting quality system information
Donawa, M.E.
Medical Device Technology 15(2): 24-27
2004
ISSN/ISBN: 1048-6690 PMID: 15154336 Document Number: 569894
The Food and Drug Administration's final guidance document on the type of quality system information that should be submitted in some types of premarket submissions was published in February 2003. The final guidance replaces previous draft guidance. This article discusses the final guidance document.
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