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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
Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations: Guidance for Sponsors, Investigators, and Institutional Review Boards  Food and Drug Administration (FDA) Final
Questions and Answers on Informed Consent Elements, 21 CFR § 50.25(c): Guidance for Sponsors, Investigators, and Institutional Review Boards  Food and Drug Administration (FDA) Final
Certificates of Confidentiality: Guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Considerations for Design, Development, and Analytical Validation of Next Generation Sequencing (NGS) - Based In Vitro Diagnostics (IVDs) Intended to Aid in the Diagnosis of Suspected Germline Diseases: Guidance for Stakeholders and Food and Drug…  Food and Drug Administration (FDA) Final
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Procedures for Evaluating Appearance Issues and Granting Authorizations for Participation in FDA Advisory Committees: Draft Guidance for the Public, FDA Advisory Committee Members, and FDA Staff  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4735 documents.