FDA's Regulation of Implantable and Wearable Sensors 2016

Key Topics

• FDA regulatory approvals for sensors
  • FDA guidance documents for sensors
  • Currently approved sensors in medicine
  • How the FDA regulates sensors
  • Global approval of sensors
  • Sensors for both diagnostic and therapeutic purposes
  • The medical device, drug and biological approval process
  • Applicable good manufacturing and good laboratory practices
  • How to design appropriate clinical trials
  • FDA and other federal agency enforcement action
  • Product labeling, marketing and advertising
• Fundamentals of sensors
  • How to build sensors
  • What is all the excitement about
  • Incorporating cells and/or biological materials into sensors
  • Wearable versus implantable sensors
  • Biological reactions to sensors
  • Avoiding immune system clearance of sensors
• Future thoughts on approaches for the regulatory approval sensors
  • Outlook for new technologies
  • Remaining hurdles

Who should Attend

• Quality professionals
• Senior quality managers
• Compliance professionals
• Regulatory professionals
• Manufacturing engineers
• Production supervisors
• Design engineers
• Production engineers
• Contract manufacturers
• Labelers and private labelers
• U.S. agents of foreign corporations
• Importers and custom agents
• Quality engineers
• Process owners
• Document control specialists
• Quality auditors
• Medical affairs
• Record retention specialists
• Financial advisors and institutional investors
• Legal professionals
• Graduate students
• Patent lawyers
• Clinicians
• Academic faculty and professors
• Entrepreneurs