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- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, July 27, 2019
- Subject(s):
- Bile Ducts
Device Approval -- standards
Self Expandable Metallic Stents -- standards
Biocompatible Materials -- standards
Materials Testing -- standards
Product Labeling -- standards
Product Packaging -- standards
Sterilization -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- Publication:
- Silver Spring, MD : Center for Devices and Radiological Health, August 30, 2019
- Subject(s):
- Compassionate Use Trials -- standards
Cost-Benefit Analysis
Device Approval -- standards
Equipment and Supplies -- classification
Uncertainty
Data Collection
Reagent Kits, Diagnostic
Research Design
Sample Size
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- Publication:
- Silver Spring, MD : Center for Devices and Radiological Health, September 6, 2019
- Subject(s):
- Compassionate Use Trials -- standards
Device Approval -- standards
Cost-Benefit Analysis
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
- Publication:
- Silver Spring, MD : Center for Devices and Radiological Health, September 13, 2019
- Subject(s):
- Device Approval -- standards
Therapeutic Equivalency
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.