American Conference
Institute (ACI) will be holding its FDA Boot Camp Devices Edition conference on
November 4-5, 2013 in Chicago, IL.  ACI
faculty will help attendees:

• 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.

In particular,
ACI's faculty will offer presentations on the following topics:

• 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);
• Navigating the
510(k) clearance process;
• Comprehending 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 November 4, 2013 from 1:00 to 4:00 pm.  A post-conference master class on
"Unique Regulatory Schemes for Specialized Devices: Medical Device
Software and Social Media Considerations in Advertising and Promotion"
will be offered from 2:00 to 5:00 pm on November 6, 2013.

An agenda for the
conference can be found here,
and more information regarding the workshop 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 workshop or master
class), or $3,295 (conference, workshop, and master class).  Those registering by September 6, 2013 will
receive a $300 discount, and those registering by October 4, 2013 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 e-mailing CustomerService@AmericanConference.com, by calling 1-888-224-2480,
or by faxing a registration form to 1-877-927-1563.

Patent Docs is a media partner of ACI's FDA Boot Camp Devices Edition conference.