Get the ultimate roadmap to navigate the complicated landscape of FDA medical device regulatory law
ACI’s FDA Boot Camp – Devices Edition delivers an in-depth coverage of FDA regulatory law to professionals who work in conjunction with the medical device industry—such as products liability specialists, in-house counsel, business development executives, and compliance professionals. In addition to providing a “basic training,” our BRAND NEW 2017 AGENDA offers “advanced training” sessions covering the “ins and outs” of applying this knowledge to real-life situation. Highlights from this year’s program include a “Ripped from the Headlines” section covering the recent hot issues of 21st Century Cures Act, Cybersecurity, and Digital Health, and their impact on FDA practice, and an in-depth Post-Conference Skills session, providing an interactive, step-by-step journey through the submission process with strategies and tips for success.A distinguished faculty of top FDA regulatory device experts — a “Who’s Who of the FDA Bar” — will share their knowledge and give you critical insights on:
• The organization, jurisdiction, functions, and operations of FDA • An overview of medical device regulations and classification • Clinical trials and IDEs • The 510(k), PMA, and de novo pathways and choosing the right one • Device labeling, promotion, and related First Amendment concerns • General post-market controls and MDRs • Quality Systems Regulation and UDI • Understanding FDA’s Enforcement authority and how to remain compliant • Recalls and WithdrawalsMaximize your knowledge and networking experience at the pre-conference primer, ethics session, and post-conference skills session:
Wednesday, July 26, 2017Workshop A
FDA Device Law 101: Introduction to the Fundamentals
Workshop B
Resolving Ethical Challenges Encountered during the Device Approval Process
Workshop C
Skills Session: Tips and Strategies for Communicating with FDA
