• Master the basics of the application and approval processes, including 510(k) clearance and PMAs;
• Navigate the complexities of device regulations;
• Comprehend the structure of the FDA and the roles of the three major agency centers: CDER, CBER, and CDRH;
• Develop a practical working knowledge of clinical trials and IDEs;
• Learn how devices are classified, monitored, and regulated;
• Recognize the pivotal role of labeling and learn how to avoid misbranding and off label promotion;
• See the importance of cGMPs and QSRs to the post-approval regulatory process; and
• Navigate the protocols of adverse events monitoring, product withdrawals, and recalls.
• The basics: Understanding and working with the FDA -- jurisdiction, functions, organization, and operations;
• Overview of device regulation;
• Understanding clinical trials and the investigational device exemption (IDE);
• Comprehending the 510(k) clearance process;
• Navigating the premarket approval process (PMA);
• Complying with general post-market controls;
• Understanding FDA enforcement tools, policies, practices, and trends;
• Labeling and promotion;
• Medical device reporting;
• Guidance for navigating recalls and withdrawals; and
• Quality system regulation.
A pre-conference primer on the "Fundamentals of FDA Device Regulatory Law," will be offered on October 23, 2012 from 1:00 - 4:00 pm. 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.
A post-conference master class on "Unique Regulatory Schemes for Specialized Devices: In Vitro Diagnostics and Software Classified as Devices" will be offered from 2:00 - 5:15 pm on October 25, 2012. The master class will provide attendees with enhanced information specific to in vitro diagnostics and software that is classified as a medical device and will help attendees thoroughly comprehend the complexities and nuances of these areas of regulatory law.
An agenda for the conference can be found here, and more information regarding the pre-conference primer and master class can be found here. A complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration form can be obtained here.
The registration fee is $2,295 (conference alone), $2,895 (conference and pre-conference primer or master class), or $3,495 (conference, pre-conference primer, and master class). Those registering by August 24, 2012 will receive a $300 discount and those registering by September 21, 2012 will receive a $200 discount. Patent Docs readers who reference the discount code "PD 200" will receive $200 off the current price tier when registering. Those interested in registering for the conference can do so here, by calling 1-888-224-2480, by faxing a registration form to 1-877-927-1563, or by e-mailing CustomerService@AmericanConference.com.
Patent Docs is a media partner of ACI's FDA Boot Camp Devices Edition conference.