title: 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 The final guidance replaces previous draft guidance.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.
authors.affiliation: Donawa & Associates Ltd, Via Fonte di Fauno 22, I-00153 Rome, Italy. donawa@srd.it
authors.forename: Maria E
authors.initials: ME
authors.lastname: Donawa
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence / Q000592:standards*; D004282:Documentation / Q000379:methods* / Q000592:standards*; D004867:Equipment Design / Q000379:methods* / Q000592:standards*; D004869:Equipment Safety / Q000379:methods / Q000592:standards; D004864:Equipment and Supplies / Q000592:standards*; D011785:Quality Assurance, Health Care / Q000331:legislation & jurisprudence / Q000592:standards*; D011786:Quality Control; D014481:United States