CfPA
Online Training Course
FDA’s 510(k) Premarket Notification
Program: What It Is and Where It’s Going
Day: Thursday, November 13, 2014 Time: 11:00 a.m.–12:30 p.m. (ET)
Location: Your Computer Offering # 1411-204 Priority Code: 520
(Available On-Demand starting 11/14/14)
WHO SHOULD ATTEND
This online training will benefit medical device industry professionals in management, compliance, clinical research, regulatory affairs, research
and development, and legal. This course would also be helpful for those who are new to the device industry or their position as well as to
investors in the device industry.
LEARNING OBJECTIVES
Upon completion of this training, you will be able to:
• Explain FDA’s current 510(k) requirements, including the three-tier classification system and the general requirements to bring a device to market
• Identify required information for a 510(k) submission and avoid potential pitfalls in a 510(k) premarket notification submission
• Anticipate potential changes to the 510(k) program and how it may affect your premarket strategy
COURSE DESCRIPTION
This 90-minute accredited online training course covers current FDA’s regulatory requirements for 510(k) premarket notifications. It includes
an overview of the general premarket requirements and details the current 510(k) requirements. Among the topics discussed are strategic
considerations in preparing a 510(k), when to submit a 510(k), and alternatives to the traditional 510(k) premarket notification. The course will
also focus on current issues with the 510(k) program, review timelines, and proposed reforms to the 510(k) program.
Module 1: Overview of Premarket Device
Requirements and 510(k) Process
• Important definitions: device, misbranded,
adulterated, substantial equivalence,
predicate device
• Premarket requirements to market a device
• Three-tier risk-based classification system
• When to file a 510(k) and FDA’s standard
of review
• Typical review cycle and timetable
Module 2: Current 510(k) Requirements
• Content of a traditional 510(k) premarket
notification and user fees
• 510(k) alternatives-Special and Abbreviated
510(k)s
• De novo review process
• Changes to a device with a cleared 510(k)
Module 3: Retooling the 510(k) Process–
Improvements and Proposed Changes
• MDUFA
• Booz Allen Hamilton Recommendations
• FDA’s Plan of Action
• Factors to consider when developing a
strategic and regulatory plan
Question and Answer Session
TUITION AND REGISTRATION
TUITION *– Single Rate: U.S. $295.00 per person
Group Rate: U.S. $245.00 per person**
Register at www.cfpa.com. Enter Course Offering #1411-204 into Quick Jump. To register use Priority Code: 520.
For Questions and Information call Customer Service at 732-613-4500.
Please Note: M
ultiple participants are not authorized to share access provided to a single registrant, a single dedicated seat license must be purchased for each individual. CfPA
reserves the right to cancel access or collect the group rate payment if this requirement has been violated. Only registered participants will receive accreditation.
System Requirements: PC-based attendees: Windows(R) 7, Vista, XP or 2003 Server/Macintosh(R)-based attendees: Mac OS(R) X 10.4.11 (Tiger(R)) or newer
For more information see reverse sidea
190 State Highway 18, Suite 203, East Brunswick NJ 08816
Phone 732-238-1600 • Fax 732-238-9113
www.cfpa.com
COURSE CO-DIRECTORS
Jacqueline J. Chan, associate, K&L Gates LLP
Jacqueline J. Chan is an associate with the global law firm K&L Gates LLP. Ms. Chan’s practice focuses on FDA law and counseling regarding
regulatory compliance and liability risks. She advises domestic and foreign pharmaceutical, device, food/food additive, cosmetic, dietary
supplement, and tobacco clients on a broad range of matters including US labeling and promotional activities, enforcement risk assessment and
defense, FDA submissions, post-marketing obligations, state regulatory compliance, and regulatory strategy development. Ms. Chan received
her law degree from the George Washington University Law School and she received her BA with honors from the Johns Hopkins University.
Suzan Onel, Partner, K&L Gates LLP
Suzan Onel is a Partner at the global law firm K&L Gates LLP and Chairs the firm’s FDA practice. Ms. Onel advises on all aspects of FDA law
and regulatory compliance across medical device, pharmaceutical, food, supplement, and cosmetic industries. She has extensive experience
representing medical equipment, in vitro diagnostic, and biotechnology companies on a wide range of issues, including market entry strategies,
premarket submissions (510(k)s, PMAs, IDEs), labeling and promotional activities, regulatory compliance, adverse event reporting, recalls and
enforcement defense. She also regularly advises clients on the development of corporate compliance programs and regulatory strategy and
conducts executive training sessions. Ms. Onel received her BA with honors in neurobiology and history from the University of Pennsylvania and
her JD from the University of Virginia School of Law. She is also a frequent author and lecturer on FDA related topics.
ACCREDITATIONS
The Center for Professional Advancement has been approved as an Authorized Provider by the International Association for Continuing Education
and Training (IACET), 1760 Old Meadow Road, Suite 500 McLean, VA 22102. In obtaining this approval, The Center for Professional Advancement
has demonstrated that it complies with the ANSI/IACET Standards which are widely recognized as standards of good practice internationally. The
Center for Professional Advancement is therefore authorized to offer IACET CEUs for its programs that qualify under the ANSI/IACET Standards.
CEU will be awarded for participation in The Center for Professional Advancement’s courses at the rate of .1 CEU per contact hour. CEU will be
awarded only upon successful completion of the entire course and 70% accuracy in the required Learners’ Assessment.
WHO WE ARE
The Center for Professional Advancement (CfPA) is the largest accredited technical training organization in the world with a curriculum of
approximately three hundred and fifty short courses in 18 industries including Pharmaceutical, Biotechnology, Medical Device, Chemical,
Cosmetics, Food and more.
Since our founding in 1967, we have successfully trained nearly a half million people worldwide in topics ranging from basic and introductory
concepts to new advances and cutting-edge technology, and current U.S. and European regulations. CfPA courses are offered in a variety of
formats – Public offering, Client Site and Online – to fit you or your company’s training needs.
For more information visit our website at www.cfpa.com
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TERMS AND CONDITIONS
*Payment: Tuition payable in US funds net of all charges. Payment is due at time of registration in the form of a credit card. Please contact CfPA’s Customer Service for other payment options.
**Group Rate: The Group Rate is for two or more enrollments, up to five registering from the same company at the same time. For groups of six or more, please contact Customer Service for group pricing.
Cancellations/No Show: “Live”- Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one
year from date of issuance. No credit will be issued for no-shows and/or cancellations less than two worki­­ng days prior to the course. : “On-Demand”- No refund or credit will be issued for
no-shows and/or cancellations of on-demand training courses. CfPA is not responsible for any outside related costs incurred by registrant’s cancellation.
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