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513. Non-clinical performance assessment of tissue containment systems used during power morcellation procedures: guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, May 26, 2023
Subject(s):
Device Approval
Government Regulation
Morcellation -- instrumentation
Morcellation -- legislation & jurisprudence
Morcellation -- standards
United States

515. Implementation of acceptable full-length and abbreviated donor history questionnaires and accompanying materials for use in screening donors of blood and blood components: guidance for industry

Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research, May 2023
Subject(s):
Blood Donation
Blood Donors
Donor Selection
Government Regulation
Mandatory Testing
Surveys and Questionnaires
United States

516. Recommendations for evaluating donor eligibility using individual risk-based questions to reduce the risk of human immunodeficiency virus transmission by blood and blood products: guidance for industry

Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research, May 2023
Subject(s):
Blood Donation
Blood Donors
Blood Transfusion
Donor Selection
Government Regulation
HIV Infections -- prevention & control
Mandatory Testing
United States

518. Presenting quantitative efficacy and risk information in direct-to-consumer (DTC) promotional labeling and advertisements: guidance for industry

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, June 2023
Subject(s):
Direct-to-Consumer Advertising -- legislation & jurisprudence
Direct-to-Consumer Advertising -- standards
Disclosure
Drug Industry
Drug Labeling -- legislation & jurisprudence
Drug Labeling -- standards
Government Regulation
United States

519. Alternative procedures for the manufacture of cold-stored platelets intended for the treatment of active bleeding when conventional platelets are not available or their use is not practical: guidance for industry

Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research, June 2023
Subject(s):
Biological Products -- standards
Blood Platelets
Government Regulation
Platelet Transfusion
Refrigeration
United States