Guidance on submitting quality system information

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 The final guidance replaces previous draft guidance.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.

Veröffentlicht von Medical device technology, 2004. Die Leitlinie selbst findest du bei der hier verlinkten Quelle.

pubmed.ncbi.nlm.nih.gov/15154336/