Subjects: Device Approval and Equipment Safety / Copyright: Public domain - Digital Collections - National Library of Medicine Search Results

Start Over Subjects Device Approval ✖ Subjects Equipment Safety ✖ Copyright Public domain ✖

1. Medical devices: cancer risk led FDA to warn against certain uses of power morcellators and recommend new labeling : report to Congressional requesters

Publication:: Washington, D.C. : U.S. Government Accountability Office, February 2017
Subject(s):: Device Approval
Equipment Safety
Morcellation -- adverse effects
Morcellation -- instrumentation
Product Labeling
Leiomyoma -- surgery
Uterine Neoplasms -- surgery
Humans
United States
United States. Food and Drug Administration

2. Emergency use authorization of medical products and related authorities: guidance for industry and other stakeholders

Publication:: Silver Spring, MD : Food and Drug Administration, U.S. Department of Health and Human Services, January 2017
Subject(s):: Civil Defense -- legislation & jurisprudence
Device Approval
Drug Approval
Emergencies
Terrorism
Emergency Medical Services
Equipment Safety
Off-Label Use
Public Health
Safety
Humans
United States
United States. Department of Health and Human Services.
United States. Department of Homeland Security.
United States. Food and Drug Administration.

3. 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.

4. Establishing the performance characteristics of in vitro diagnostic devices for the detection or detection and differentiation of human papillomaviruses: guidance for Industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, September 15, 2017
Subject(s):: Device Approval
Papillomavirus Infections -- diagnosis
Reagent Kits, Diagnostic -- standards
Cervix Uteri -- cytology
Cervix Uteri -- virology
Equipment Failure
Equipment Safety
Genotyping Techniques -- standards
Mass Screening
Papillomaviridae -- classification
Papillomaviridae -- genetics
Quality Control
Reference Standards
Reproducibility of Results
Research Design
Specimen Handling
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

5. Self-monitoring blood glucose test systems for over-the-counter use: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, September 29, 2020
Subject(s):: Blood Glucose Self-Monitoring
Device Approval
Equipment Safety
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

6. Use of International Standard ISO 10993-1: "Biological evaluation of medical devices - part 1 : evaluation and testing within a risk management process" : guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, September 4, 2020
Subject(s):: Device Approval
Equipment Failure
Equipment Safety
Equipment and Supplies -- standards
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

7. Safer technologies program for medical devices: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, January 6, 2021
Subject(s):: Device Approval
Equipment Safety
Voluntary Programs
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

8. Testing and labeling medical devices for safety in the magnetic resonance (MR) environment: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, May 20, 2021
Subject(s):: Device Approval
Equipment Safety
Magnetic Resonance Imaging -- instrumentation
Product Labeling
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

9. Peripheral vascular atherectomy devices: premarket notification [510(k)] submissions : guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, May 20, 2021
Subject(s):: Atherectomy -- instrumentation
Device Approval
Equipment Safety
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

10. Facet screw systems: performance criteria for safety and performance based pathway : guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, April 13, 2022
Subject(s):: Bone Screws -- standards
Device Approval
Equipment Safety
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration