Subjects: Equipment Safety and United States. Food and Drug Administration. - Digital Collections - National Library of Medicine Search Results

Start Over Subjects Equipment Safety ✖ Subjects United States. Food and Drug Administration. ✖

1. 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.

2. Blood glucose monitoring test systems for prescription point-of-care 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
Equipment Safety
Point-of-Care Testing
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

3. Breast implants: certain labeling recommendations to improve patient communication : guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, September 29, 2020
Subject(s):: Breast Implants
Equipment Safety
Product Labeling
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

4. CT contrast media power injectors can rupture conventional IV sets

Publication:: [Harrisburg, Pa.] : Pennsylvania Patient Safety Authority, c2008
Subject(s):: Contrast Media
Cross Infection -- prevention & control
Equipment Failure
Injections, Intravenous -- instrumentation
Tomography, X-Ray Computed -- instrumentation
Equipment Safety
Guidelines as Topic
Pressure
Humans
Pennsylvania
United States
United States. Food and Drug Administration.

5. Class II special controls guideline: in vitro diagnostic devices for Bacillus spp. detection : guideline for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, April 1, 2019
Subject(s):: Bacillus
Equipment Safety
Reagent Kits, Diagnostic -- classification
Reagent Kits, Diagnostic -- standards
Bacteriophage Typing -- classification
Enzyme-Linked Immunosorbent Assay -- classification
Fluorescent Antibody Technique -- classification
Nucleic Acid Amplification Techniques -- classification
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

6. Classification and requirements for laser illuminated projectors (LIPs): (Laser Notice No. 57) : guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, May 8, 2019
Subject(s):: Equipment Safety
Lasers -- classification
Lasers -- standards
Device Approval
Lasers -- adverse effects
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

7. 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.

8. 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.

9. The effects of drug shortages on unsafe injection practices

Publication:: [Harrisburg, Pa.] : Pennsylvania Patient Safety Authority, c2012
Subject(s):: Equipment Contamination -- prevention & control
Equipment Reuse
Equipment Safety
Injections -- adverse effects
Pharmaceutical Preparations -- supply & distribution
Humans
Pennsylvania
United States
United States. Food and Drug Administration.

10. 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.