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2941. Policy for coronavirus disease-2019 tests during the public health emergency (revised): immediately in effect guidance for clinical laboratories, commercial manufacturers, and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, May 11, 2020
Subject(s):
Clinical Laboratory Techniques
COVID-19 Serological Testing
COVID-19 Testing
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

2943. Submission of plans for cigarette packages and cigarette advertisements (revised)

Publication:
Silver Spring, MD : Center for Tobacco Products, July 2021
Subject(s):
Cigarette Smoking -- adverse effects
Cigarette Smoking -- prevention & control
Product Packaging
Tobacco Products -- adverse effects
Tobacco Products -- supply & distribution
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

2944. Required warnings for cigarette packages and advertisements: small entity compliance guide (revised)

Publication:
Silver Spring, MD : Center for Tobacco Products, July 2021
Subject(s):
Cigarette Smoking -- adverse effects
Cigarette Smoking -- prevention & control
Product Packaging
Tobacco Products -- adverse effects
Tobacco Products -- supply & distribution
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

2945. Enforcement policy for face masks and respirators during the coronavirus disease (COVID-19) public health emergency (revised): guidance for industry and food and drug administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, May 2020
Subject(s):
COVID-19 -- prevention & control
Masks
N95 Respirators
Personal Protective Equipment
Respiratory Protective Devices
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

2948. Wholesale distributor verification requirement for saleable returned drug product and dispenser verification requirements when investigating a suspect or illegitimate product: compliance policies

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, October 2020
Subject(s):
Drug Industry
Drug and Narcotic Control
Pharmaceutical Preparations
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

2949. 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.

2950. 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.