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1453. 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.

1456. Transition plan for medical devices that fall within enforcement policies issued during the coronavirus disease 2019 (COVID-19) public health emergency: guidance for industry, other stakeholders, and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, March 27, 2023
Subject(s):
Equipment and Supplies
Government Regulation
Medical Device Legislation
COVID-19
United States
United States. Food and Drug Administration

1457. Transition plan for medical devices issued emergency use authorizations (EUAs) related to coronavirus disease 2019 (COVID-19): guidance for industry, other stakeholders, and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, March 27, 2023
Subject(s):
Equipment and Supplies
Government Regulation
Medical Device Legislation
COVID-19
United States
United States. Food and Drug Administration

1458. Enforcement policy for face masks and barrier face coverings during the coronavirus disease (COVID-19) public health emergency: guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, March 13, 2023
Subject(s):
COVID-19 -- prevention & control
Government Regulation
Masks -- standards
Medical Device Legislation
Personal Protective Equipment
United States
United States. Food and Drug Administration

1459. Enforcement policy for face shields, surgical masks, and respirators during the coronavirus disease (COVID-19) public health emergency: guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, March 13, 2023
Subject(s):
COVID-19 -- prevention & control
Government Regulation
Masks -- standards
Medical Device Legislation
N95 Respirators -- standards
Personal Protective Equipment
Respiratory Protective Devices -- standards
United States
United States. Food and Drug Administration

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