When to conduct a recall and whether to report it are some of the most difficult decisions that medical device manufacturers face. To complicate matters, in February 2013, FDA issued a draft guidance that is intended help differentiate between a medical device recall and a product enhancement. However, the draft guidance has raised new questions about what constitutes a recall and when FDA notification is necessary. The following presentation will discuss:
- Factors to consider when deciding whether to recall a device.
- When a recall must be reported and the potential implications of FDA’s new draft guidance.
- The FDA enforcement risk associated with failing to comply with reporting requirements.
- How to avoid common recall-related pitfalls.
- Systemic actions that can be taken to ensure recalls are conducted properly
Participants that will find this webinar most beneficial will be those involved in medical device companies. Job titles of attendees that will be most applicable for this session will be:
- Regulatory Affairs & Operations
- Post-Market Surveillance & Vigilance
- Adverse Event, Safety & Complaint Manager
- Quality Assurance
- General Counsel
Pamela Furman Forrest, Partner, King & Spalding LLP
Pamela Furman Forrest is a Partner in King & Spalding’s FDA/Life Sciences Practice Group. Her practice focuses on FDA medical device matters, including premarket notification, premarket approval, product recalls, Medical Device Reporting (MDR), Quality System Regulation (QSR) compliance, labeling and promotion, and clinical research requirements. Ms. Forrest also frequently assists firms in responding to FDA enforcement actions. In addition, much of her work focuses on conducting FDA-related due diligence activities in connection with mergers and acquisitions of medical device firms. She has written and spoken extensively on FDA medical device regulation, and has testified before several state legislative committees regarding medical device legal and regulatory issues. Ms. Forrest graduated summa cum laude, Phi Beta Kappa, from Yale University in 1988, with a Bachelor of Arts in political science. She received her law degree from Stanford Law School in 1994.