Medical device technology
Guidance on submitting quality system information
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 The final guidance replaces previous draft guidance.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.
Source and rights
Published by Medical device technology, 2004. The guideline itself is at the source linked here.
Prognia summarises this guideline for reference and education. It is not medical advice. Always check the official guideline and current local protocols before acting on it.
At a glance
- Published
- 2004
- Applies to
- 🌐 International
- Country of origin
- 🇮🇹 Italy
- Scope
- International
- Journal
- Medical device technology
- PubMed
- 15154336
- Added to Prognia
- 23 July 2026
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