1. CDRH Reorganization: Impact on DCD Structure
February 26, 2012
Matthew Hillebrenner, MSE
Deputy Director
Division of Cardiovascular Devices

2. Disclosures
I have no conflicts of interest to disclose

3. DCD Reorganization 8 Branch structure (formerly 5)
Smaller branch size, improved staff to manager ratio
Several potential benefits
Allow for greater focus on staff development
Enable continued hiring to meet resource needs
Increase BC ability to engage in scientific issues
Improve recruitment/retention of BCs
Effort made to maintain continuity in areas of review responsibility

4. DCD Reorganized Structure

5. DCD Reorganized Structure

6. Cardiac Diagnostics Devices Branch
Acting Branch Chief: Linda Ricci
Devices reviewed:
Blood pressure monitors
Implantable hemodynamic EP monitors
Arrhythmia detectors
ECG
Multiparameter monitors
Diagnostic computers
External defibrillation
Diagnostic catheters

7. Cardiac Electrophysiology Devices Branch
Branch Chief: Felipe Aguel, PhD
Devices reviewed:
Ablation catheters
Ablation surgical instruments
Mapping catheters
Mapping systems

8. Implantable Electrophysiology Devices Branch
Branch Chief: Mitchell Shein
Devices reviewed:
Pacemakers
Defibrillators
Cardiac resynchronization therapy (CRT)
Nerve stimulators
Leads

9. DCD Reorganized Structure

10. Circulatory Support Devices Branch
Acting Branch Chief: Fernando Aguel, MSE
Devices reviewed:
Ventricular assist devices (VADs)
Total artificial hearts
Cardiopulmonary bypass
Autotransfusion
CPR devices
Injectable polymers for HF
Hypothermia
Thermal regulating systems
Compressible limb sleeves

11. Interventional Cardiology Devices Branch
Acting Branch Chief: Melissa Torres, MSE
Devices reviewed:
Coronary stents
PTCA catheters
Coronary guidewires and introducers,
Coronary guide/support/infusion catheters
Coronary atherectomy/embolectomy
Aortic coarctation stents

12. Structural Heart Devices Branch
Branch Chief: Sonna Patel-Raman, PhD
Devices reviewed:
Replacement heart valves
Heart valve repair devices
Cardiac occluders
Balloon valvuloplasty
Adhesion barriers
Pericardial patches
Vessel guard
Vascular closure devices

13. DCD Reorganized Structure

14. Peripheral Interventional Devices Branch
Acting Branch Chief: Lisa Lim, PhD
Devices reviewed:
Peripheral Stents
Peripheral atherectomy/embolectomy catheters
Embolic protection
Angioplasty catheters
Peripheral guidewires/introducers
Peripheral guide/support/infusion catheters

15. Vascular Surgery Devices Branch
Branch Chief: Kenneth Cavanaugh, PhD
Devices reviewed:
Endovascular grafts
Vascular surgical sealants
Vascular surgical grafts
IVC filters
Vascular embolization
Vascular clamps

16. Change is in the air… New organizational structure
Review of manufacturing changes
FDASIA impact on clinical trials
Benefit-Risk Assessments
Improvements in post-market surveillance
Innovation initiatives
…MDUFA 3

17. Questions?