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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
Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics : Guidance for Stakeholders and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests (Revised): Guidance for Test Developers and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Gifts to FDA: Evaluation and Acceptance: Guidance for the Public and FDA Staff  Food and Drug Administration (FDA) Final
Public Availability of Advisory Committee Members' Financial Interest Information and Waivers: Guidance for the Public, FDA Advisory Committee Members, and FDA Staff  Food and Drug Administration (FDA) Final
The Open Public Hearing at FDA Advisory Committee Meetings: Guidance for the Public, FDA Advisory Committee Members, and FDA Staff  Food and Drug Administration (FDA) Final
Procedures for Evaluating Appearance Issues and Granting Authorizations for Participation in FDA Advisory Committees: Draft Guidance for the Public, FDA Advisory Committee Members, and FDA Staff  Food and Drug Administration (FDA) Proposed
Determination of the Period Covered by a No-Tobacco-Sale Order and Compliance With an Order: Guidance for Tobacco Retailers  Food and Drug Administration (FDA) Final
General Questions and Answers on the Ban of Cigarettes that Contain Certain Characterizing Flavors (Edition 2): Guidance to Industry and FDA Staff  Food and Drug Administration (FDA) Final
Compliance Policy for Combination Product Postmarketing Safety Reporting: Immediately in Effect Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently Asked Questions Statement of Investigator (Form FDA 1572) (Revision 1): Draft Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently…  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4741 documents.