FDA Regulations: Medical Devices

Who Should Participate?

• Personnel in medical device establishments
• Leading managers
• Regulatory affair personnel
• Quality assurance personnel
• Production personnel
• Engineers
• Technology research and develpment specialists
• Clinical trial specialist
• Clinical toxiology researchers

Training Outline

• Laws, regulations, and guidelines
• Definition of medical devices
  • Combination products
• Three dteps of spplication
  • Medical devices and radiological products
  • Classification
  • Exemption
• Other tequirements in application
  • Labeling
  • Registration
  • Listing
  • Quality system or GMP
    • Third party inspection
  • Medical Device Reporting, MDR
  • Exemption requirements
  • Application view, approval and fee
  • Investigational Device Exemption, IDE
  • Premarket Notification, 510(K)
  • Premarket Approval, PMA
  • Product Development Protocol, PDP
  • Expedited review criteria
  • Third party review
• Device inport and export in U.S. market
  • Procedurces and key points
  • Mutual Recognition Agrccment (MRA)
  • STED and GHTF