Transcript FDA Perspective on C..

FDA Perspective on
Cardiovascular Device
Development
Bram D. Zuckerman, M.D.
Director
Division of Cardiovascular
Devices (HFZ-450)
[email protected]
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 Drug Evaluation
And Research
(CDER)
Center for Biologics
Evaluation and Research
(CBER)
Center for Devices and
Radiological Health
(CDRH)
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
Total Product Life Cycle
Coated
Stents
Coated
Stents
Brachytherapy
Total Product Life Cycle
Engineering
Biocompatibility
D esign
Toxicology
Mode of
Action
End of
Life
Hazard
Analysis
Risk
Analysis
Clinical
Sciences
Study D esign
Statistics
Review Sciences
Post-M arketing
Surveillance
Environm ent
Adverse
Event
Reporting
Forensic
Engineering
Epidemiology
Quality
Systems
Reuse
Sterility
EMC
Shock
Vibration
Total Product Life Cycle
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)
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)
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
1
3
“One size doesn’t fit all”
Communication (FDA,
Industry, &
Investigators) is
essential
2.
Pre-IDE/IDE
Mtg