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1. Use of real-world evidence to support regulatory decision-making for medical devices: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, August 31, 2017
Subject(s):
Equipment and Supplies
Equipment Safety
Evidence-Based Medicine
Product Surveillance, Postmarketing
Data Collection
Data Interpretation, Statistical
Decision Making
Device Approval
Quality Control
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

2. Understanding the impacts of OS-PCORTF projects on data capacity: an interim qualitative assessment

Author(s):
Evans, Emily, (Of Office of the Assistant Secretary for Planning and Evaluation), author
Srinivasan, Mithuna, author
Correa, Kiran, author
Ryan, Sofia, author
Harmsen, Mikaela, author
Lumsden, Susan, author
Dullabh, Prashila, author
Publication:
Washington, D.C. : Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation ; [Chicago, Illinois] : NORC, September 2023
Subject(s):
Data Collection
Evidence-Based Medicine
Patient-Centered Care
Qualitative Research
United States