Mission: CDRH promotes
and protects the health of the public by ensuring the safety and
effectiveness of medical devices and the safety of radiological
products.
Vision: Ensuring the health of the public through out the Total
Product Life Cycle |
Public Health Impact
Measure, assess, improve and communicate our impact on public health
|
Magnet for Excellence
Attract and retain a diverse work force to accomplish our public
health mission
|
CDRH
Strategic
Goals
|
Knowledge Management
Enhance use of information and communication systems to support
TPLC
|
TPLC
Align CDRH programs to effectively manage the product life cycle
|
Meet MDUFMA performance goals
|
Strengthen our work-force for the 21st
century |
CDRH
Priorities |
Enhance our knowledge management
|
Achieve better pre/postmarket regulatory
balance
|
Public Health Promotion
Assess and improve time to market for medical devices
Public Health Protection
Assess and improve risk management, identifying and resolving public
health hazards
|
Workforce Excellence
Attract, develop and retain a highly skilled and diverse workforce
to advance our public health mission
|
Scorecard
Key Result
Areas |
Knowledge Management
Communicating with our stakeholders to meet public health challenges
throughout the TPLC
|
Total Product Life Cycle
Effective Management in Accordance with TPLC Principles
|
- Meet FY 05 MDUFMA decision and cycle goals
- Initiate quality system for application review
- Timely and high quality review consults
- Conditions of approval studies
- Risk -based inspections
- Enhance MedSun and build LabSun
- Expedite analysis of reported serious injuries
- Emergency Measures
|
- Priority hiring
- Increase professional development
- Expand use of external expertise through MDFP and other initiatives
|
Focus Areas
|
- Guidance development
- Targeted IT initiatives, including premarket review modernization,
electronic applications , electronic registration & listing, and
postmarket electronic reporting
- Infrastructure upgrades, including IMAGE2000 and tracking system
updates
- Turbo 510(k)
- E-consults
- Disease-specific websites and real time web notifications
|
- Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Model
- Research prioritization
- Radiological health strategy
- GHTF
- Organizational scorecards
- Project management plans
- Move to White Oak
|
Technology Development and Innovation
Patient and Consumer Protection
Protecting the Homeland -- Counter Terrorism
Risk-Based Management Practices |
Improving FDA's Business Practices
|
Relationship to
FDA Goals |
Patient and Consumer Protection
Empowering Consumers in Public Health
|
Improving FDA's Business Practices
|
