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The top documents tagged [diagnostic device evaluation]

Department of Health and Human Services IVD Validation and Regulation in Rx/Dx Combinations FDA/Industry Statistics Workshop Classifiers in Combination
Department of Health and Human Services IVD Validation and Regulation in Rx/Dx Combinations FDA/Industry Statistics Workshop Classifiers in Combination
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1 FDA Perspective: FDA Evaluation of Point of Care Blood Glucose Meters Patricia Bernhardt, M.T.(ASCP), Scientific Reviewer Office of in Vitro Diagnostic
1 FDA Perspective: FDA Evaluation of Point of Care Blood Glucose Meters Patricia Bernhardt, M.T.(ASCP), Scientific Reviewer Office of in Vitro Diagnostic
217 views
Entering the US Market: Medical Devices Carole C. Carey BSEE, M.Engineering carole.carey@fda.hhs.gov Director, International Staff US Food and Drug Administration
Entering the US Market: Medical Devices Carole C. Carey BSEE, M.Engineering [email protected] Director, International Staff US Food and Drug Administration
226 views
U.S. Food and Drug Administration Center for Devices and Radiological Health 2009 Sep 29 Edmonton, Oct 1 Vancouver How does the U.S. FDA Regulate Medical
U.S. Food and Drug Administration Center for Devices and Radiological Health 2009 Sep 29 Edmonton, Oct 1 Vancouver How does the U.S. FDA Regulate Medical
215 views
Multiplex
Multiplex
1.219 views
Use of Outside Experts in FDAs Premarket Evaluation of Medical Devices Donna-Bea Tillman AU/OPM II AU/OPM II December 2004 An Action Learning Project Mans
Use of Outside Experts in FDAs Premarket Evaluation of Medical Devices Donna-Bea Tillman AU/OPM II AU/OPM II December 2004 An Action Learning Project Mans
215 views
FDA’s History with Lab Developed Tests Public Meeting on Oversight of Laboratory Developed Tests July 19 – 20, 2010 Courtney C. Harper, Ph.D. Office of
FDA’s History with Lab Developed Tests Public Meeting on Oversight of Laboratory Developed Tests July 19 – 20, 2010 Courtney C. Harper, Ph.D. Office of
215 views
CDRH OTC Review Practice, BPAC, 0511031 CDRH Review Practice for Over-the-Counter in Vitro Diagnostic Tests Center for Devices and Radiological Health
CDRH OTC Review Practice, BPAC, 0511031 CDRH Review Practice for Over-the-Counter in Vitro Diagnostic Tests Center for Devices and Radiological Health
216 views
1 The FDA Approval Process Evidence to Support the Adoption of New Biomarkers Diagnostic Course, Queen’s College, Oxford September 2014 Sally A. Hojvat,
1 The FDA Approval Process Evidence to Support the Adoption of New Biomarkers Diagnostic Course, Queen’s College, Oxford September 2014 Sally A. Hojvat,
216 views
Premarket Review Performance Goals Donna-Bea Tillman Director, Office of Device Evaluation Director, Office of Device Evaluation Don St. Pierre Deputy
Premarket Review Performance Goals Donna-Bea Tillman Director, Office of Device Evaluation Director, Office of Device Evaluation Don St. Pierre Deputy
214 views
FDA Regulation of In Vitro Diagnostic Tests FDA Regulation of In Vitro Diagnostic Tests FDA Public Meeting on Oversight of Laboratory Developed Tests July
FDA Regulation of In Vitro Diagnostic Tests FDA Regulation of In Vitro Diagnostic Tests FDA Public Meeting on Oversight of Laboratory Developed Tests July
229 views
FDA Regulation of In Vitro Diagnostic Tests
FDA Regulation of In Vitro Diagnostic Tests
87 views