9:00-9:30 am

The US Food and Drug Administration’s Regulation of Medical Devices
John Manthei, Partner, Latham & Watkins LLP

• Purpose of a 510(k)
  
• Types of 510(k)s
  
• Who must file a 510(k)
  
• Definition of "substantial equivalence"

9:30 – 10:30 am

Format and Content of a 510(k)
Janice Brown, RAC, Director of Regulatory Affairs – Medical Imaging, Boston Scientific Corporation

• Information required by FDA regulations
  
• Communicating with FDA prior to submission
  
• Selecting a predicate device
  
• Obtaining and presenting data in support of a 510(k)
  
• Case study

10:30–10:45 am

Break

10:45–11:30 am

The 510(k) Process Review Considerations
Miriam C. Provost, PhD, Senior Project Manager, M Squared Associates, Inc., Former Deputy Director of Science and Engineering Review in the Office of Device Evaluation at FDA

• Review considerations
  
  • Intended use and predicate devices
    
  • Technology and use of data
    
  • Safety and efficacy questions
    
• Review Process
  
• FDA perspective on successful submissions

11:30–12:00 pm

When No Predicate is Available: The De Novo Classification Process
John Manthei, Partner, Latham & Watkins LLP

• Historical regulation of low-risk devices with no predicates
  
• FDAMA Section 207: FDA's de novo classification process
  
• Content of a de novo classification request
  
• Managing communications with FDA
  
• What types of devices are suitable for de novo classification? Examples

12:00 – 12:30 pm

Post-Market Considerations: Maximizing Your 510(k) Clearance
Linda D'Abate, Vice President, The Weinberg Group

• Modifications to your cleared intended use: When are new submissions required?
  
• Device Modifications
  
• Determining and Documenting Decisions Not to Submit (FDA Flow Chart)

12:30 – 1:00 pm

Lunch

1:00 – 2:30 pm

The Premarket Approval (PMA) Process
Miriam C. Provost, PhD, Senior Project Manager, M Squared Associates, Inc., Former Deputy Director of Science and Engineering Review in the Office of Device Evaluation at FDA

• Content requirements
• Determining the indications for use
• Drafting summaries of safety and effectiveness and labeling
• Manufacturing information
• Organizing your submission: dos and don'ts
• Generating pre-clinical and clinical data
• Points to consider for a successful submission
  

2:30 – 2:45 pm

Break

2:45– 3:15 pm

Clinical Trial Considerations
Ben Haas, Associate, Latham & Watkins LLP

• FDA's investigation device regulations (IDE)
  
• Good laboratory practices
  
• Ensuring adequate informed consent
  
• Fulfilling sponsor, monitor, and investigator requirements
  
• Pre IDE meeting: maximizing your time with FDA
  
• Clinical trial agreements: Protect yourself and your investments

3:15 – 3:30 pm

Avoiding Fraud and Abuse in Clinical Trials
Andrew Gantt, Partner, Latham & Watkins LLP

• Key fraud and abuse principles applicable to clinical trials
  
• How to structure clinical trial arrangements with principle investigators and trial sites
  
• Billing medicare and other third party payors for investigational devices and procedures - recent developments
  

3:30– 3:45 pm

Break

3:45 – 4:30 pm

Devising a Product Reimbursement Strategy
Andrew Gantt, Partner, Latham & Watkins LLP

• How criteria for product coverage and reimbursement differs from that fro FDA approval
  
• Timing for consideration of reimbursment strategy
  
• Identifying the right patient population for the trial protocol
  
• Identifying covered products in relevant market area
  
• How to structure study protocols to highlight outcomes necessary for coverage and reimbursement
  
• navigating the coverage and reimbursement process

4:30 – 5:00 pm

Post-Market Considerations
Ben Haas, Associate, Latham & Watkins LLP

• PMA supplements
  
• Annual reports
  
• Post-market studies
  
• Other post-market considerations