December 8-9, 2011
Baltimore, MD

ABOUT THE CONFERENCE

The medical device industry is experiencing greater regulatory scrutiny from FDA; several instances of device failures and high profile recalls have resulted in the agency looking closer at devices on the market and their approval processes. Changes to popular approval routes such as the 510(k) are up for reconsideration. With budgets throughout the industry already stretched, changes to regulatory directives are causing confusion and concern, as indications point to more clinical research data being required, longer trials being conducted and longer times to market. This conference will provide clarity to new regulatory pathways for device approvals and regulatory oversight.

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TOPICS TO BE COVERED

• Understanding Changes to the 510(k) Regulatory Process
  
• Improving Transparency & Communication from the Agency to the Public
  
• Achieving a Better Understanding of how FDA Scrutinizes Predicate Devices
  
• Assurance Case Reports & its Impact on 510(k) Submissions
  
• Comprehending FDA's Regulatory Approval Process for Combination Products
  
• Using Pre-IDE Meetings to Streamline the IDE Process
  
• Panel Discussion: Q&A Sessions with FDA Representatives
  
• Evaluating Recent FDA Approvals
• Exploring the Usefulness of the De Novo Process
  
• Case Study: A Look at the Modular PMA Process
• Navigating the Regulatory Process in Europe
• Examining FDA Rules Governing Social Media
• Reviewing Recent Enforcement Actions Regarding Off-Label Use
  
• Examining the Latest Recall Cases in the Medical Device Industry
  
• Investigating Trends in Warning Letters Issued by the FDA

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ADD TO CALENDAR

KEY PRESENTERS TO INCLUDE

Christy Foreman
Director, Office of Device Evaluation
Center for Devices & Radiological Health, FDA

Nicole Wolanski
Director, Premarket Approval Section
Center for Devices & Radiological Health, FDA

Richard C. Chapman, BA, MS
Chief, General Hospital Devices Branch, Division of Anesthesiology, General Hospital, Infection Control & Dental Devices
Center for Devices & Radiological Health, FDA

Jonette Foy, PhD
Acting Deputy Director, Science & Regulatory Policy
Center for Devices & Radiological Health, FDA

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