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22. Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, May 2020
Subject(s):
Device Approval
COVID-19
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

23. Necessary automated external defibrillator accessories: policy regarding compliance date : guidance for industry, stakeholders, health care professionals, and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, October 28, 2020
Subject(s):
Defibrillators
Device Approval
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

24. 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.

25. 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.

28. Mouse embryo assay for assisted reproduction technology devices: guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, January 5, 2021
Subject(s):
Biological Assay
Device Approval
Embryo, Mammalian
Mice
Reproductive Techniques, Assisted
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

29. Effects of the COVID-19 public health emergency on formal meetings and user fee applications for medical devices: questions and answers (revised) : guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, June 2020
Subject(s):
Device Approval
COVID-19
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration