Medical device makers will have an opportunity to learn the ins and outs of the FDA regulatory process and structure during the American Conference Institute’s FDA Boot Camp Devices Edition conference, Oct 25 and 26, in Chicago. Presentations will cover:  

• Basics of the application and approval processes, including 510(k) clearance and PMAs.
• Complexities of device regulations.
• Structure of the FDA and the roles of the three major agency centers:  Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), and Center for Devices and Radiological Health (CDRH).
• Basics of clinical trials and investigational device exemptions (IDEs).
• How devices are classified, monitored, and regulated.
• Role of labeling and how to avoid misbranding and off label promotion.
• Importance of current good manufacturing practices (cGMPs) and quality system regulations (QSRs) to the post-approval regulatory process.
• How to navigate the protocols of adverse events monitoring, product withdrawals, and recalls.

A preconference training session on the "Fundamentals of FDA Regulatory Law," will be offered Oct 24. The workshop will provide a basic overview of FDA regulations and will prepare attendees for the in-depth discussions that will take place throughout the conference.

Two concurrent post-conference master classes will be offered Oct 26. The first, titled "Staying Ahead of the Curve: FDA's Regulation of In Vitro Diagnostics and Laboratory Developed Tests," will provide an in-depth overview of the FDA regulatory structure governing IVDs, and the coming changes that will regulate LDTs. The second master class, titled "Software as a Medical Device: Understanding the Nuances of FDA Regulation," will address issues that are encountered when dealing with software classified as medical devices.