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The Recall Challenge: Determining When to Conduct a Recall and Whether to Report It
The Recall Challenge: Determining When to Conduct a Recall and Whether to Report It


 
Our Price: $395.00

Product Code: WB-7040
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About the Product
Includes 1 hour and 5 minute Windows Media Video File and PowerPoint presentations for immediate download.

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 To complicate matters, in February 2013, FDA issued a draft guidance that is intended help differentiate between a medical device recall and a product enhancement. However, the draft guidance has raised new questions about what constitutes a recall and when FDA notification is necessary.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  • When a recall must be reported and the potential implications of FDA’s new draft guidance.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

Speaker:
Pamela Furman Forrest
Partner
King & Spalding’s FDA/Life Sciences Practice Group


Target Audience

  • Regulatory Affairs & Operations
  • Post-Market Surveillance & Vigilance
  • Adverse Event, Safety & Complaint Manager
  • Quality Assurance
  • General Counsel

Target Industry

  • Medical Device Manufacturers

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