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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
Bridging for Drug-Device and Biologic-Device Combination Products: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Medical Device Accessories - Describing Accessories and Classification Pathways: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Minimizing Risk for Children's Toy Laser Products: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices : Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Institutional Review Board (IRB) Review of Individual Patient Expanded Access Submissions for Investigational Drugs and Biological Products: Guidance for IRBs and Clinical Investigators  Food and Drug Administration (FDA) Final
Advanced Prostate Cancer: Developing Gonadotropin-Releasing Hormone Analogues Guidance for Industry: Clinical/Medical  Food and Drug Administration (FDA) Final
Providing Regulatory Submissions in Electronic Format Orphan-Drug and Humanitarian Use Device Designation Requests and Related Submissions: Draft Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Antiviral Product Development — Conducting and Submitting Virology Studies to the Agency: Guidance for Submitting HIV-1 Resistance Data: Attachment to the Guidance: Draft Draft Guidance: This draft guidance updates the final guidance posted 6/2/06  Food and Drug Administration (FDA) Proposed
Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture: Final Guidance  Food and Drug Administration (FDA) Final
Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion: Final Guidance for Industry  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.