ACI’s 5th Annual FDA Boot Camp: Devices EditionMay 12, 2017
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.