Get the ultimate roadmap to navigate the complicated landscape of FDA medical device regulatory law
NEW 2016 AGENDA. This year’s FDA Boot Camp-Devices Edition has been revamped to provide both a “basic training” in FDA regulatory law, as well as “advanced training” sessions tailored to the application of this knowledge to real-life situations. Highlights from this year’s program include a “Ripped from the Headlines” panel, containing updates on key developments in the FDA regulatory bar, and an in-depth Post- Conference Master Class, delving into the hot-button topics of in vitro diagnostics, laboratory developed tests, companion diagnostics,and combination products.
ACI’s FDA Boot Camp – Devices Edition has been designed by leading regulatory attorneys to give professionals who work in conjunction with the medical device industry—such as products liability specialists, in-house counsel, business development executives, and compliance professionals—a strong working knowledge of core FDA competencies.
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
- The classification of devices and the concept of “risk-based” classification
- Clinical trials and IDEs
- The 510(k) clearance process – what you need to know now and what to expect in the future
- The premarket approval (PMA) process, drug labeling, and promotion
- General post-market controls and MDRs
- QSRs vs. cGMPs and ISO
- Mitigating the impact of enforcement actions
- Recalls, product withdrawals, and FDA’s oversight authority
Attend the pre-conference primer and post-conference master class to get the background and/or the in-depth information you need to maximize your learning and networking experience at this event!Pre-Conference Primer A: Fundamentals of FDA Regulatory Device Law
- This primer will address topics to set the stage for the main conference by helping you thoroughly comprehend the structure of FDA and the essentials of the pre-approval, approval, and post-approval process. Get the background you need to flow seamlessly into the conversations at FDA Boot Camp – Devices Edition.
Post- Conference Master Class B: Laboratory Developed Tests and Companion Diagnostics and In Vitro Diagnostics, Oh My! and Unlocking the Combination: Decoding the Unique Challenges of Combination Products
- This master class will provide an in-depth overview of the potential expansion of FDA’s regulatory oversight of LDTs in light of the guidance. How to determine what qualifies as an LDT, how the guidance will apply, and what roadblocks may affect the marketing of your LDT.
- The class will also address how to choose the right pathway for your combination product and ensuring that FDA follows its own rules regarding classification of these products. This class further deals with the issues in execution of regulatory and compliance requirements within this unique product arena.
Attend this conference and learn to navigate your way through the regulatory maze that plays such a crucial role to your cases and practice areas. Seating is limited; don’t delay — register now by calling 1-888-224-2480, faxing your registration form to 1-877-927-1563, or registering online.