High-Risk Devices: Parsing the Premarket Approval Process (PMA)

July 27, 2017 11:30am

Yarmela Pavlovic
Partner
Hogan Lovells US LLP (San Francisco, CA)

  • Determining eligibility for PMA
  •  Navigating through the steps of the PMA process
    • Pre-Submission and Pre-PMA processes
    • Original PMA Submission
    • Planning for Day 100 Meetings
    • Amendments and responding to Agency Deficiencies
    • PMA Decision
    • Withdrawal of approval/temporary suspension of PMA approval
    • Post-approval requirements
  •   Other Considerations
    • Expedited Access Pathway for unmet medical needs for life threatening or irreversibly debilitating diseases or conditions
    • Priority Review
  • Understanding Clinical Trials and Investigational Device Exemption (IDE)
  • Humanitarian Use Devices
    • HDE applications and amendments
    • Denial of approval or withdrawal of approval of an HDE