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PubMed · 15154336

Guidance on submitting quality system information.

Maria E Donawa
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Abstract

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 The final guidance replaces previous draft guidance.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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Device ApprovalDocumentationEquipment DesignEquipment SafetyEquipment and SuppliesQuality Assurance, Health CareQuality ControlUnited StatesGuidelineJournal Article

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Maria E Donawa. 2004. Guidance on submitting quality system information.. https://pubmed.ncbi.nlm.nih.gov/15154336/

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