510(k) Premarket Notifications:  The Laws and Regulations

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"

Preparing a 510(k)

Kenneth Kleinhenz, Senior Director, Quality Assurance and Regulatory Affairs, Cytori Therapeutics

• 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

Break

The 510(k) Decision-Making Process

Heather Rosecrans, Director, 510(k) Staff, Office of Device Evaluation, Center for Devices and Radiological Health, FDA

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

When a Predicate Device is Unavailable: De Novo Submissions

Ben Haas, Associate, 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

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)

Lunch

Premarket Approval (PMA) Applications: How to Prepare a PMA

Phil Phillips, MBA, Director, Medical Device Practice, Becker & Associates Consulting

• Content requirements
  
• Determining the indications for use
  
• Drafting summaries of safety and effectiveness and labeling
  
• Manufacturing information
  
• Organizing your submission: dos and don'ts
  

FDA's Review Process

John Manthei, Partner, Latham & Watkins LLP

• Review procedures and timelines
  
• Traditional PMAs
  
• Modular PMAs
  
• Deficiency letters/PMA amendments
  
• Preparing for panel meetings
  
• Inspections
  
• Managing communications with FDA

The Big Picture: Generating Clinical and Pre-clinical Data that Maximizes the Utility of Your PMA

Phil Phillips, MBA, Director, Medical Device Practice, Becker & Associates Consulting

• Determining how much pre-clinical and clinical data to collect
  
• CMS coverage and reimbursement considerations

FDA's Good Clinical Practice Regulations

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

FDA Perspective on Successful Submissions

Miriam Provost PhD, Deputy Director, Division of General, Restorative and Neurological Devices, Office of Device Evaluation, Center for Devices and Radiological Health , FDA

5:00 – 5:30 p.m.

Post-Market Considerations

John Manthei, Partner, Latham & Watkins LLP

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

 TOP