Recall Guidance for Drugs, Biologics, and Medical Devices: What You Need to Know

September 19, 2014 11:30am


Mark Mansour
Jones Day

  • What is the FDA’s recall and oversight authority (overview of 21 CFR Part 7)?
    • guidance versus regulation
    • voluntary recalls versus mandatory recalls
    • market withdrawals and stock recoveries
  • What medical device recalls need to be reported to FDA?
  • When should a company institute a recall? Can new labeling or a new product warning constitute a recall?
  • Working with the FDA versus going it alone
  • Interaction between recalls and corrective and preventive action
  • FDA seizure and injunction power
  • When can product be reintroduced to the market?