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Start Over Subjects Device Approval ✖Remove constraint Subjects: Device Approval

61. Cybersecurity in medical devices: refuse to accept policy for cyber devices and related systems under section 524B of the FD&C Act : guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, March 30, 2023
Subject(s):
Computer Security -- legislation & jurisprudence
Device Approval
Equipment Safety
Government Regulation
United States
United States.

65. Non-clinical performance assessment of tissue containment systems used during power morcellation procedures: guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, May 26, 2023
Subject(s):
Device Approval
Government Regulation
Morcellation -- instrumentation
Morcellation -- legislation & jurisprudence
Morcellation -- standards
United States

66. Hydrogen peroxide-based contact lens care products: consumer labeling recommendations : premarket notification (510(k)) submissions : guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, July 27, 2023
Subject(s):
Contact Lens Solutions
Device Approval
Government Regulation
Hydrogen Peroxide
Product Labeling
United States
United States. Food and Drug Administration

70. 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 8, 2023
Subject(s):
Biological evaluation of medical devices
Device Approval
Equipment and Supplies -- adverse effects
Government Regulation
Guidelines as Topic
United States