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

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. guide manufacturers in product development
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) 5

4. Total Product Life Cycle
Coated Stents
Coated Stents
Brachytherapy

5. Total Product Life Cycle

6. Total Product Life Cycle
And they interconnect. They interconnect because all parts of the cycle inform and are pathways to other parts. They interconnect because products further along in the cycle inform and affect new products earlier in the cycle. They interconnect because a safe and effective device or radiological health product can’t be developed without some knowledge of all the parts.
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) 5

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) 5

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
Number of full scale studies usually required
Number of Regulatory Classes

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