CBI's Executive Summit on Disseminating Off-Label Information - Guidelines for Medical Device and Diagnostic Manufacturers

Product Liability is a huge issue for device manufacturers because many of their products could be purposely used for an alternative indication or entirely misused by the patient. Huge liability questions arise when devices are used for off-label uses, particularly those promoted by the manufacturer. For many products, off-label uses outnumber uses that have been approved by the FDA. Learn how a manufacturer can lessen their product liability risk:

• Understand how "promotion" of off-label use can play into litigation
  
• Determine when the FDA becomes involved in product liability suits
  
• Evaluate how recent government enforcement activities are affecting medical device products liability litigation
  
• How will product label changes affect subsequent litigation?
  
• What are the fraud and abuse implications of off-label promotion and use?

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