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