FDA Quality System Regulation | (21 CFR Part 820)

  • This is a quality system regulation, not a voluntary standard
  • The QSR is generic in nature due to the fact that there are more than 12k devices in the marketplace
  • Management is held accountable for the quality management system
  • The QSR is applicable to organizations who sell a medical device in the US, regardless of their geographic location
  • Not all requirements are applicable to low-risk devices (class 1)
  • The QSR Regulation addresses the following areas:
    • design controls
    • material controls
    • management
    • corrective and preventive actions
    • production and process controls
    • equipment and facility controls
    • document and record controls
  • FDA can take enforcement action for non-compliance with the QSR
  • Specific requirements for device labeling, complaint handling and recalls appear in other regulations.