Subjects: Equipment Safety / Genre: Technical Report / Copyright: Public domain / Dates by Range: 2000 and later - Digital Collections - National Library of Medicine Search Results

Start Over Subjects Equipment Safety ✖ Genre Technical Report ✖ Copyright Public domain ✖ Dates by Range 2000 and later ✖

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. FDA medical device reviews: evaluation is needed to assure requests for additional information follow a least burdensome approach : report to Congressional requestors

Publication:: Washington, DC : United States Government Accountability Office, December 2017
Subject(s):: Device Approval -- standards
Equipment Safety
Federal Government
Forecasting
Government Regulation
Inservice Training
Humans
United States
United States. Food and Drug Administration.

6. Conventional Foley catheters--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, August 14, 2020
Subject(s):: Equipment Design
Equipment Safety
Urinary Catheterization
Urinary Catheters -- standards
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

7. Cutaneous electrodes for recording purposes--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, August 14, 2020
Subject(s):: Electrodes
Equipment Design
Equipment Safety
Electrocardiography
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

8. 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.

9. Technical considerations for non-clinical assessment of medical devices containing nitinol: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, July 9, 2021
Subject(s):: Alloys
Equipment Design
Equipment Safety
Nickel
Titanium
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

10. Basic safety and essential performance of medical electrical equipment, medical electrical systems, and laboratory medical equipment: standards specific information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program : guidance for industry, accreditation bodies, testing laboratories, and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, September 25, 2020
Subject(s):: Accreditation
Electricity
Equipment Safety
Equipment and Supplies
Mechanical Tests
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.