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Start Over Subjects Equipment Safety ✖Remove constraint Subjects: Equipment Safety

51. 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.

52. 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.

53. 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

54. Orthopedic non-spinal metallic bone screws and washers: 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 Screws
Equipment Safety
Orthopedic Equipment
Orthopedic Fixation Devices
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

55. Magnetic resonance (MR) receive-only coil: 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):
Equipment Safety
Magnetic Resonance Imaging
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

57. 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

58. 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

59. 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

60. 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