Recalls and Withdrawals

July 22, 2016 11:00am

Stephen Terman
Olson Frank Weeda Terman Matz, PC (Washington, DC)

Joseph Falvo
Sr. Manager Post-Market Risk Management
Ortho-Clinical Diagnostics

  • How are device recalls different from drug recalls?
  • What medical device recalls must be reported to FDA?
  • FDA’s recall and oversight authority
    • 21 CFR part 7
    • Voluntary vs. mandatory recalls
    • 21 CFR part 810 – Mandatory Medical Device Recall Procedures
      • Cease distribution and notification order
      • Regulatory hearing
      • Mandatory recall order
      • Termination of a cease distribution and notification or mandatory recall order
      • Public notice
    • Part 806, Corrections and removals reporting
    • When should a company institute a recall?
      • Can new labeling or new product warning constitute a recall?
    • When should the decision be made to work with FDA?
      • Working with FDA vs. working alone
      • Risks and benefits of each course of action
    • Consequences of not instituting a recall
    • FDA seizure and injunction power
    • Post-recall surveillance issues
    • Reintroducing a product to the market