Understanding the FDA
Q1: History of FDA
Q2: Structure of FDA/CDRH
Q3: CDRH vs. CDER
Q4: Device/Drug Combinations
Q5: External influences on FDA
Q6: Advice for Innovators
Q7: CMS and FDA
Working with the FDA
Q1: Targeting FDA Branches
Q2: Who Companies Work with at FDA
Q3: How Branch makes a Difference
Q4: When to Interact with FDA
Q5: Benefits of Meeting with FDA
Q6: Developing a Relationship with FDA
Q7: Downside to Meeting with FDA
Q8: Case Study: Building a Relationship
Q9: Other Advice
First Steps in the Regulatory Process
Q1: What Should Innovators Think About
Q2: Classification of a Device
Q3: Navigating the Pathway Decision
Q4: Using the De Novo Pathway
Q5: Choosing a Predicate
Q6: 510(k) and Market Potential
Q7: Investigational Device Exemption
Q8: Pointers for Submissions
Q9: How to Approach the Assignment of a Panel
Q10:One Final Tip
Assembling a Regulatory Team
Q1: Guiding Principal: Building a Team
Q2: Internal vs. External Regulatory Help
Q3: Timing for Regulatory Assistance
Q4: What to Look for in a Consultant
Q5: How to Find/Hire a Consultant
Q6: Working with a Consultant
510(k) vs. PMA Regulatory Strategies
Q1: Basics of 510(k) Clearance Process
Q2: Concerns about 510(k) Process
Q3: Basics of PMA Approval Process
Q4: Key Differences: 510(k) vs. PMA
Q5: Approaching FDA w/Multiple Areas
Q6: Care as Device Moves to Market
Investigational Device Exemptions
Q1: Need for Clinical Trials
Q2: US vs. Outside US trials
Q3: Role of Investigational Device Exemption
Q4: Need for Meeting w/FDA prior to IDE
Q5: Advice for FDA Meetings prior to IDE
Case Example: The Acclarent Regulatory Strategy
Q1: About Acclarent
Q2: About Balloon Sinuplasty
Q3: Acclarent’s Regulatory Strategy Timing
Q4: Determining Branch at FDA
Q5: Determining Device Classification
Q6: Determining Regulatory Pathway
Q7: Reasons to Choose 510(k)
Q8: Concerns with Chosen Pathway
Q9: Choosing Predicates
Q10: 510(k) Submission Experience
Q11: Clinical Data Requirements
Q12: First Interaction with FDA
Q13: Time to Clearance
Q14: Post Clearance Analysis
Regulatory Case Studies
Q1: Perclose: 510(k) vs. PMA
Q2: Neuroretrieval Devices: Pathway Strategy
Q3: Emphasys: Expert Panels
Q4: Cyberonics: Overcoming Panel Recommendations