CfPA
Online Training Course
FDA's 510(k) Premarket Notification Program:
What It Is and Where It's Going
NEW
Day: Wednesday, March 9, 2011 Time: 11:00 a.m.–12:30 p.m. (ET)
Location: Your Computer Offering # 1103-209 Priority Code: 520 (Available On-Demand starting 2/11/11)
This course presented by CfPA in conjunction wiith
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, proposed reforms to the 510(k) program, and likely timelines.
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: Proposed Reforms to the 510(k)
Program–How Did We Get Here and Likely
Next Steps
• “Hot” reforms being proposed to the
510(k) program
• What prompted these reforms
• Likely timelines
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 #1103-209 into Quick Jump. To register use Priority Code: 520.
For Questions and Information call Customer Service at 732-613-4500.
Please Note: Multiple 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
PO Box 7077, East Brunswick NJ 08816
Phone 732-238-1600 • Fax 732-238-9113
www.cfpa.com
COURSE DIRECTOR
Suzan Onel, Partner in the global law firm K&L Gates LLP
Ms. Onel leads the device practice in Washington, DC and has over two decades experience in FDA-regulated matters. Ms. Onel's practice
covers all issues related to FDA including food, drug, medical device, dietary supplement, clinical investigator, and cosmetic law. She routinely
counsels domestic and international companies on market entry strategies, premarket applications and notifications, labeling, promotional
activities, regulatory compliance, due diligence investigations, recalls and enforcement defense. Ms. Onel's experience includes extensive
interaction with the U.S. Food and Drug Administration, the Federal Trade Commission, the Consumer Product Safety Commission, the
National Advertising Division of the Better Business Bureaus, and similar state and international bodies. She is a frequent author and lecturer
on FDA matters including combination products, medical device software, dietary supplements, and functional foods. She received her
Bachelors degree with honors in neurobiology and history from the University of Pennsylvania and her law degree from the University of Virginia
School of Law.
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.
CEUs will be awarded only upon successful completion of the course, i.e., attendance at essentially all the formal training and a minimum score of
70% on the 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
ABOUT MEDICAL DEVICE SUMMIT
Medical Device Summit publishes news, technology, trends, regulations, and opinions, as well as offers educational, career advancement and
networking opportunities to the global medical device and diagnostics industry. This information exchange is facilitated through ePublishing,
digital and live events. By providing such an exchange of knowledge and technologies, MedicalDeviceSummit hopes to help advance the
progress of the global medical device and diagnostic industry, thus, contributing to a healthier world.
MedicalDeviceSummit.com is an online meeting place and industry specific web site for the global medical device industry. The content is a mix
of journalistic-style articles, technical articles, blogs, white papers, press releases and news.
For more information visit their website at www.medicaldevicesummit.com or email rbiros@InnovativePublishing.net.
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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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