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HHS Guidance Portal

The Guidance Portal is a public website that shows current guidance documents from the U.S. Department of Health and Human Services (HHS) and its Divisions.

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date
Recommendations for Microbial Vectors Used for Gene Therapy: Guidance for Industry  Food and Drug Administration (FDA) Final
Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor Screening Tests Using Cadaveric Blood Specimens from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Guidance for Industry  Food and Drug Administration (FDA) Final
Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation: Guidance for Industry  Food and Drug Administration (FDA) Final
Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis: Guidance for Industry  Food and Drug Administration (FDA) Final
Recommendations for Screening, Testing, and Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis: Guidance for Industry  Food and Drug Administration (FDA) Final
Recommendations for the Submission of LOINC® Codes in Regulatory Applications to the U.S. Food and Drug Administration: Guidance for Industry  Food and Drug Administration (FDA) Final
Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components: Guidance for Industry  Food and Drug Administration (FDA) Final
Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria: Guidance for Industry  Food and Drug Administration (FDA) Final
Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments: Guidance for Industry  Food and Drug Administration (FDA) Final
Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) - Small Entity Compliance Guide: Guidance for Industry  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.