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Start Over Subjects COVID-19 ✖Remove constraint Subjects: COVID-19 Subjects United States. Department of Health and Human Services. ✖Remove constraint Subjects: United States. Department of Health and Human Services.

11. Enforcement policy for infusion pumps and accessories 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, Office of Product Evaluation and Quality, April 2020
Subject(s):
Infusion Pumps
COVID-19
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

12. Enforcement policy for remote ophthalmic assessment and monitoring devices 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, Office of Product Evaluation and Quality 2020
Subject(s):
Remote Consultation
Telemedicine -- instrumentation
Tonometry, Ocular -- instrumentation
Vision Tests -- instrumentation
Wireless Technology -- instrumentation
COVID-19
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

13. Temporary policy regarding non-standard PPE practices for sterile compounding by pharmacy compounders not registered as outsourcing facilities during the COVID-19 public health emergency

Publication:
[Silver Spring, MD] : Center for Drug Evaluation and Research, Office of Compliance, April 2020
Subject(s):
Drug Compounding -- methods
Personal Protective Equipment -- supply & distribution
COVID-19
Sterilization -- methods
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

14. Policy for the temporary use of portable cryogenic containers not in compliance with 21 CFR 211.94(e)(1) for oxygen and nitrogen during the COVID-19 public health emergency

Publication:
[Silver Spring, MD] : Center for Drug Evaluation and Research, April 2020
Subject(s):
Nitrogen -- supply & distribution
Oxygen -- supply & distribution
COVID-19
Nitrogen -- therapeutic use
Oxygen -- therapeutic use
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

17. Enforcement policy for non-invasive remote monitoring devices used to support patient monitoring during the coronavirus disease 2019 (COVID-19) public health emergency (revised): guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Drug Evaluation and Research, October 2020
Subject(s):
COVID-19
Monitoring, Physiologic
Remote Sensing Technology
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

18. Temporary policy for preparation of certain alcohol-based hand sanitizer products during the public health emergency (COVID-19)

Publication:
[Silver Spring, MD] : Center for Drug Evaluation and Research, February 10, 2021
Subject(s):
Drug Compounding -- methods
Drug Compounding -- standards
Ethanol
Hand Sanitizers
COVID-19
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

19. Policy for temporary compounding of certain alcohol-based hand sanitizer products during the public health emergency: immediately in effect guidance for industry

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, February 10, 2021
Subject(s):
Drug Compounding -- methods
Drug Compounding -- standards
Ethanol
Hand Sanitizers
Methanol
COVID-19
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

20. 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.