FDA Guidance for Industry: Quality Management System Information for Certain Premarket Submission Reviews

FDA Guidance for Industry: Quality Management System Information for Certain Premarket Submission Reviews

FDA is issuing this draft document to provide guidance to industry and FDA staff about FDA expectations related to the Quality Management System Regulation (QMSR) requirements and Quality Management System (QMS) information included in premarket approval applications (PMAs) and Humanitarian Device Exemption (HDE) applications