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Start Over Subjects Equipment Safety ✖Remove constraint Subjects: Equipment Safety Dates by Range 2000 and later ✖Remove constraint Dates by Range: 2000 and later

41. 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.

42. 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.

43. 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.

44. 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.

45. 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.

47. 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.

48. 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.

49. 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.

50. 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