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

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1. 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.

2. 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.

3. 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.

4. Spinal plating 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, December 11, 2020
Subject(s):: Bone Plates
Equipment Design
Equipment Safety
Spinal Cord
Spinal Fusion
Materials Testing
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

5. Implanted brain-computer interface (BCI) devices for patients with paralysis or amputation: non-clinical testing and clinical considerations : guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, May 20, 2021
Subject(s):: Amputation
Brain-Computer Interfaces
Equipment Design
Equipment Safety
Paralysis
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

6. Technical considerations for medical devices with physiologic closed-loop control technology: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, September 29, 2023
Subject(s):: Equipment Design
Equipment Safety
Government Regulation
Medical Device Legislation
Monitoring, Physiologic
United States

7. Digital health technologies for remote data acquisition in clinical investigations: guidance for industry, investigators, and other stakeholders

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, December 2023
Subject(s):: Data Collection
Digital Health
Equipment Design
Equipment Safety
Government Regulation
Medical Device Legislation
Remote Sensing Technology -- standards
United States