FDA Perspective on Cardiovascular Device Development

1. FDA Perspective on Cardiovascular Device Development Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices (HFZ-450) bdz@cdrh.fda.gov

2. FDA Organizational Chart Department of Health and Human Services Center for Veterinary Medicine Center for Food Safety And Applied Nutrition Food and Drug Administration Office of the Commissioner National Center for Toxicological Research Center for Biologics Evaluation and Research (CBER) Center for Drug Evaluation And Research (CDER) Center for Devices and Radiological Health (CDRH)

3. CDRH Mission: Ensure medical devices are safe and effective via premarket and postmarket evaluation • guide manufacturers in product development • evaluate data submitted on device design, performance, and clinical use • authorize marketing of devices found safe and effective • ensure that claims are supported by valid scientific evidence • focus special emphasis on medical breakthrough devices (expedited review)

4. Total Product Life Cycle CoatedStents Coated Stents Brachytherapy

5. Total Product Life Cycle

6. Total Product Life Cycle The Pipeline

7. DCD Challenges • Improved interaction with scientific community • Meet user fee goals • Development of better treatment strategies for atherosclerotic disease and diabetic vascular disease • Improved post-market reporting • Focus special emphasis on medical breakthrough devices (expedited review)

8. How Do We Get There? • Improved interaction with scientific community • Meet user fee goals • Development of better treatment strategies for atherosclerotic disease and diabetic vascular disease • Improved post-market reporting • Focus special emphasis on medical breakthrough devices (expedited review)

9. Comparison of Device and Drug Development Developmental Feature Device Dr Rate of technolology High Low Ease of in vitro assessment High Low Reimbursement during clinical trials Frequent Rare Influence of physician technique on result High Low Ability to visualize performance after use High Low Definition of “Orphan” (number of patients) 4,000 200,000 Number of full scale studies usually required 1 2 Number of Regulatory Classes 3 1

10. “One size doesn’t fit all” Communication (FDA, Industry, & Investigators) is essential 2. Pre-IDE/IDE Mtg 3. Good planning shortens the timeline