FDA Seeks to "Strengthen" CDRH

The FDA Center for Devices and Radiological Health - CDRH - continues it's efforts to, as it states, strengthen CDRH and increase our ability to protect and promote the public health through the implementation of changes and improvements. CDRH 2011 Strategic Priorities PDF

The outline of the CDRH 2011 Strategic Priorities includes:

• Priority 1. Fully Implement a Total Product Life Cycle Approach
  • Strategy 1.1. Enhance and Integrate Premarket, Postmarket, and Compliance Information and Functions
    • 1.1.1. Strengthen Premarket Review
    • 1.1.2. Align Scientific Resources throughout CDRH
    • 1.1.3. Optimize Data Collection and Analysis
    • 1.1.4. Address Challenges Associated with Globalization
    • 1.1.5. Enhance Compliance Capability
• Priority 2. Enhance Communication and Transparency
  • Strategy 2.1. Implement a Strategic Approach to Stakeholder Communication and Improve Communication with CDRH staff
  • Strategy 2.2. Increase Transparency and Facilitate External Communications
• Priority 3. Strengthen Our Workforce and Workplace
  • Strategy 3.1. Develop a Life Cycle Approach to CDRH Employee Education
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  • Strategy 3.2. Promote Transparent Employee Performance Review and Meaningful Recognition
  • Strategy 3.3. Improve Workload Management
  • Strategy 3.4. Develop Meaningful Metrics
• Priority 4. Proactively Facilitate Innovation and Address Unmet Public Health Needs
  • Strategy 4.1. Foster the Development of Innovative Medical Devices
  • Strategy 4.2. Develop a Personalized Medicine Program

The FDA's CDRH is still working to implement their strategic plan but a key component we feel is the implementation of the 510(k) Working Group recommendations (August 2010 Preliminary Report).