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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 Collecting Red Blood Cells by Automated Apheresis Methods - Technical Correction February 2001: Guidance for Industry  Food and Drug Administration (FDA) Final
Recommendations for Deferral of Donors and Quarantine and Retrieval of Blood and Blood Products in Recent Recipients of Smallpox Vaccine (Vaccinia Virus) and Certain Contacts of Smallpox Vaccine Recipients: Guidance for Industry  Food and Drug Administration (FDA) Final
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  Food and Drug Administration (FDA) Final
Recommendations for Investigational and Licensed COVID-19 Convalescent Plasma: Guidance for Industry  Food and Drug Administration (FDA) Final
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
This Guidance Portal contains 4735 documents.