Whether you are a new professional in the medical device industry or seasoned regulatory affairs and legal professional needing a refresher on current FDA medical device regulatory developments, you will benefit from this two-day interactive program. Hear from experts who will review the essential elements of Food and Drug Administration (FDA) medical device regulation in a systematic and comprehensive way.

Experts in the field will help you:

• Focus on the broad legal framework of device regulation, FDA’s organizational structure and pre-market requirements.
• Understand postmarket requirements, Quality System Regulation (QSR), adverse reporting, and advertising and promotion.
• Understand key regulations and policies and differentiate how those regulations and policies are applied.
• Prepare a successful 510(k) submission.
• Identify new and developing FDA policies and procedures affecting all phases of medical device regulation.
• Examine how FDA uses its statutory authority and some of the emerging issues in the ever-changing FDA regulatory landscape.

This meeting can help you and your organization comply with FDA regulations, get products approved, and help minimize regulatory problems.

Who Should Attend

• Medical Device sector of FDLI membership
• Industry professionals working in regulatory and clinical affairs, research and development, operations and quality control, and management
• Associates in law firms and other lawyers who have an interest in learning the medical device regulatory process
• Personnel in legal departments at medical device companies, Contract Research Organizations (CROs) and other medical device focused organizations