Radiation Biodosimetry Development Program
Important Links
Food and Drug Administration (FDA): Center for Devices and Radiological Health (CDRH) Medical Device Innovation Initiative (May 22, 2006)
Meetings
NIAID/CMCR Workshop on the FDA Pre-Market Regulatory Process: Applications to Technologies for Radiation Biodosimetry After a Large-Scale Radiological Incident, March 27th, 2006, Bethesda, MD
March 27, 2006 Meeting Slides
The FDA Pre-Market Regulatory Process (PDF)
Presented by: Mary Pastel, Associate Director for Advanced In Vitro Diagnostics, Office of In Vitro Diagnostic Device Evaluation and Safety and Office of Science and Engineering Laboratories, CDRH, FDA
Pre-IDE Processing (PDF)
Presented by: Sousan Altaie, Scientific Policy Advisor, Office of In Vitro Diagnostic Device Evaluation and Safety, CDRH, FDA
Data Analysis: Software and Statistics (PDF)
Presented by: Estelle Russek-Cohen, Team Leader and Mathematical Statistician, Diagnostic Devices Branch, Division of Biostatistics, Office of Surveillance and Biometrics, CDRH, FDA
Role of the Clinical Laboratory Improvement Amendments (CLIA) Program (PDF)
Presented by: James Cometa, Team Leader/Program Analyst, Centers for Medicare & Medicaid Services, Survey and Certification Group, Division of Laboratory Services
Publications
Technology Assessment and Roadmap for the Emergency Radiation Dose Assessment Program March 2005 (PDF)
U.S. Department of Homeland Security, Science and Technology
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