Recalls and Withdrawals

July 28, 2017 12:00pm

Amanda Klingler
King & Spalding LLP (Washington, DC)

Frederick A. Stearns
Keller and Heckman LLP (Washington, DC)

  • Differentiating device recalls from drug recalls
  • Evaluating FDA reporting requirements for device recalls
  • Examining FDA’s recall and oversight authority
    • 21 CFR part 7
    • Voluntary vs. mandatory recalls
    • Seizure and injunction powers
    • 21 CFR part 810 – Mandatory Medical Device Recall Procedures
      • Cease distribution and notification order
      • Regulatory hearing
      • Mandatory recall order
      • Public notice
    • Part 806, Corrections and removals reporting
  • Weighing the pros and cons of working with FDA vs. alone
  • Consequences of not instituting a recall
  • Post-recall surveillance issues
  • Reintroducing a product to the market