FDA Perspective on Cardiovascular Device Development

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Presentation transcript:

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

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)

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

Total Product Life Cycle Coated Stents Coated Stents Brachytherapy

Total Product Life Cycle

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

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

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

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

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