FDA Medical Device Regulation for the Beginner 2012

Key Topics

• Statutory and Regulatory Authority
• Organizational Structure
• Class I Medical Devices, 510(k) Premarket Notification and Premarket Approval
• Medical Device Classification System
• The Components of a 510(k) Premarket Notification
• The Process for Bringing a Medical Device to Market in the U.S
• User Fees
• A Manufacturer`s Responsibilities
• An Introduction to the Quality System Regulation (21 CFR Part 820)
• Labeling and Promotion
• Inspections
• The Import / Export of Medical Devices
• FDA Enforcement Activities

Who should Attend

• Managers
• Regulatory Affairs Professionals
• Scientists
• Consultants
• State Policy Officials
• Research Analysts
• Investment Analysts and Venture Capitalists
• Insurers focusing on Representations & Warranties Insurance
• Financial analysts and investors watching the life sciences industries
• Medical Device and Biotech Companies, Start-ups, Foreign Manufacturers, Importers, Labelers, Pharmacists, Convenience Kit Manufacturers