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CfPA - The Center for Professional Advancement, 90 Minute Accredited Online Training/In Conjunction with Medical Device Summit
February 10, 2011 at 11:00 a.m.–12:30 p.m. (ET)
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. 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
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Organized by:
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CfPA - The Center for Professional Advancement |
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Invited Speakers:
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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.
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Deadline for Abstracts:
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n/a
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Registration:
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Please click here for registration information.
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E-mail:
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sberg@cfpa.com
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