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3061. 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.

3062. 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.

3064. Certificates of confidentiality: guidance for sponsors, sponsor-investigators, researchers, industry, and food and drug administration staff

Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research September 2020
Subject(s):
Biomedical Research
Confidentiality
Privacy
Research Subjects
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

3067. Assessing COVID-19-related symptoms in outpatient adult and adolescent subjects in clinical trials of drugs and biological products for COVID-19 prevention or treatment

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, September 2020
Subject(s):
Clinical Trials as Topic
COVID-19 -- drug therapy
COVID-19 -- prevention & control
Outpatients
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

3069. Importation of certain FDA approved human prescription drugs, including biological products, and combination products under section 801(d)(1)(b) of the Federal Food, Drug, and Cosmetic Act

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, September 2020
Subject(s):
Biological Products
Drug Labeling
Prescription Drugs
Counterfeit Drugs
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

3070. Recognition and withdrawal of voluntary consensus standards: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, September 15, 2020
Subject(s):
Consensus
Equipment and Supplies -- standards
Voluntary Programs -- standards
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.