General Information


Introduction to Medical Device Law and Regulation: The Legal Framework for Medical Device Regulation 

October 8 - 9, 2013 | Crowne Plaza Cabana Hotel | Palo Alto, CA



Audience: 

Medical Device

Level:

Introductory


Who Should Attend

  • Medical Device Sector of FDLI membership
  • Regulatory and clinical affairs, legal, compliance, research and development, quality control, marketing, and management professionals in the medical device industry 
  • Reviewers of device applications 
  • Law firm associates, lawyers and consultants who have an interest in medical device regulation




This in-depth, interactive two-day course is beneficial for new professionals in the medical device industry or seasoned regulatory affairs or legal professionals looking for a refresher on current FDA medical device regulatory developments.  Attendees will hear from experts who will review the essential elements of medical device regulation.  
Course Session Topics include:
  • A primer on the legal framework of device regulation, FDA’s organizational structure and pre-market requirements
  • FDA’s statutory authority, and emerging issues in the ever-changing regulatory landscape
  • Key regulations and policies and how those regulations and policies are applied
  • Postmarket requirements, Quality System (QS) Regulation, adverse event reporting, and advertising and promotion restrictions
  • How to prepare a successful 510(k) submission
  • New and developing FDA policies and procedures affecting all phases of medical device regulation
Participating in this meeting can help you understand FDA regulations, support your efforts to get products approved, and know when FDA is likely to allege violations of the law.