3rd Annual FDA Boot Camp Devices Edition 2013

Topics

• An overview of medical device regulations
• The organization, jurisdiction, functions, and operations of the FDA
• Clinical trials and IDEs
• The classification of devices and the concept of "risk-based" classification
• The premarket approval process (PMAs) and drug labeling and promotion
• The 510(k) clearance process – what you need to know now and what to expect in the future
• QSRs vs. cGMPs and ISO
• General post-market controls and MDRs
• Recalls, product withdrawals, and FDA oversight authority
• Mitigating the impact of enforcement actions

Who should Attend

• In-house counsel with responsibility for:
  • Patents and IP
  • Litigation
  • Investment Bankers and Venture Capitalists
  • Securities Attorneys
• Attorneys whose practices focus on:
  • Patent litigation
  • Products liability litigation
  • Patent prosecution