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Start Over Collections Health Policy and Services Research ✖Remove constraint Collections: Health Policy and Services Research Subjects Product Surveillance, Postmarketing ✖Remove constraint Subjects: Product Surveillance, Postmarketing

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. Evaluation and reporting of age-, race-, and ethnicity-specific data in medical device clinical studies: guidance for Industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, September 12, 2017
Subject(s):
Clinical Trials as Topic
Demography
Device Approval
Research Design
Age Factors
Continental Population Groups
Ethnic Groups
Product Surveillance, Postmarketing
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

3. Implantable devices: regulatory framework and reform options

Author(s):
Lind, Keith D., author
Publication:
Washington, DC : AARP Public Policy Institute, August 2017
Subject(s):
Government Regulation
Prostheses and Implants -- adverse effects
Prostheses and Implants -- standards
Clinical Trials as Topic
Device Approval
Equipment Failure
Equipment Safety
Product Surveillance, Postmarketing
Registries
Humans
United States
United States. Food and Drug Administration.

5. Postmarketing adverse event reporting for medical products and dietary supplements during a pandemic

Publication:
Silver Spring, MD : Office of Counterterrorism and Emerging Threats, May 2020
Subject(s):
Dietary Supplements -- adverse effects
Drug-Related Side Effects and Adverse Reactions
Equipment Design -- adverse effects
Equipment Safety
Product Surveillance, Postmarketing
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.