The American Conference Institute’s (“ACI’s”) 5th annual “FDA Boot Camp: Devices Edition” conference is coming up fast! The conference will take place from July 26-28, 2017 in Chicago, Illinois.
ACI’s FDA Boot Camp: Devices Edition delivers in-depth coverage of FDA regulatory law to professionals who work in conjunction with the medical device industry. In addition to providing a “basic training,” ACI’s brand new 2017 agenda offers “advanced training” sessions covering the “ins and outs” of applying this knowledge to real-life situations. 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 Withdrawals
Hyman, Phelps & McNamara, P.C.’s Jeffrey N. Gibbs will be speaking at a session titled “Low to Moderate-Risk Devices: Weighing the Pros and Cons of 510(k) Clearance vs. De Novo Pathways.” FDA Law Blog is a conference media partner. As such, we can offer our readers a special 10% discount. The discount code is: P10-670-FDALB17. You can access the conference brochure and sign up for the event here. We look forward to seeing you at the conference.