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

July 21, 2016 11:30am

Kristin Zielinski Duggan
Senior Associate
Hogan Lovells US LLP

Brian J. Malkin
Senior Counsel
McGuireWoods LLP

  • What devices are subject to the PMA process?
    • Pre-amendment devices/Rulemaking
    • Post-amendment devices/Order
    • Novel high risk devices
  • Navigating the PMA application process
    • Pre-Submission Process
    • Submission
    • Amendments
    • Timing
    • Expedited Access Pathway for unmet medical needs for life threatening or irreversibly debilitating diseases or conditions
      • Goal of reducing time and costs from development to market
      • Deciding when to choose the EAP pathway
  • FDA action on a PMA
    • Timing
    • Filing decision
    • Day 100 meeting
    • Panel
    • Decision
    • Post-approval requirements
      • post-market surveillance
  • Understanding Clinical Trials and Investigational Device Exemption (IDE)
    • When does FDA require clinical data
    • Early feasibility studies and when to use them
    • When is an IDE required and what is the process for obtaining approval?
    • Regulatory requirements
      • Labeling of investigational devices
      • Prohibition of promotion and other practices
      • IRB review and approval
      • Investigator obligations
      • Records and reports
  • Humanitarian Use Devices
    • HDE applications and amendments
    • Institutional Review Board requirements
    • Post-approval requirements and reports
  • Deciding how and when to appeal