NLM Digital Collections

Search

Start Over Formats Text ✖Remove constraint Formats: Text Genre Technical Report ✖Remove constraint Genre: Technical Report

3051. 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.

3052. Postmarketing adverse event reporting for medical products and dietary supplements during a pandemic

Publication:
Silver Spring, MD : Office of Counterterrorism and Emerging Threats, May 2020
Subject(s):
Dietary Supplements -- adverse effects
Drug-Related Side Effects and Adverse Reactions
Equipment Design -- adverse effects
Equipment Safety
Product Surveillance, Postmarketing
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

3053. 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.

3055. 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.

3056. 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.

3057. 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.

3060. 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.