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Search results for "substantial equivalence"

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Viewing 1 - 20 of 29 results by relevance
Consensus Study Report

Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years  (2011)

Proceedings

Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing Patient Safety and Innovation: Workshop Report  (2010)

Proceedings

Public Health Effectiveness of the FDA 510(k) Clearance Process: Measuring Postmarket Performance and Other Select Topics: Workshop Report  (2011)

Consensus Study Report

Certifying Personal Protective Technologies: Improving Worker Safety  (2011)

Consensus Study Report

Evolution of Translational Omics: Lessons Learned and the Path Forward  (2012)

Proceedings

Developing Technologies for Early Detection of Breast Cancer: Summary of Public Workshop #2  (2000)

Consensus Study Report

Safe Medical Devices for Children  (2006)

Proceedings

Genome-Based Diagnostics: Clarifying Pathways to Clinical Use: Workshop Summary  (2012)

Consensus Study Report

Assessing Genetic Risks: Implications for Health and Social Policy  (1994)

Proceedings

Systems for Research and Evaluation for Translating Genome-Based Discoveries for Health: Workshop Summary  (2009)

Proceedings

Generating Evidence for Genomic Diagnostic Test Development: Workshop Summary  (2011)

Consensus Study Report

Extending Medicare Reimbursement in Clinical Trials  (2000)

Consensus Study Report

The Changing Economics of Medical Technology  (1991)

Food and Drug Administration Advisory Committees  (1992)

Consensus Study Report

Modern Methods of Clinical Investigation  (1990)

Consensus Study Report

Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk  (2015)

Consensus Study Report

Hearing Health Care for Adults: Priorities for Improving Access and Affordability  (2016)

Consensus Study Report

Frameworks for Protecting Workers and the Public from Inhalation Hazards  (2022)