Skip to main content
U.S. flag

An official website of the United States government

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.

Filter Guidance Documents by ...

HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date
Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs  Food and Drug Administration (FDA) Final
Minutes of Institutional Review Board (IRB) Meetings: Guidance for Institutions and IRBs  Food and Drug Administration (FDA) Final
Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions: Guidance for Investigational Device Exemption Sponsors, Sponsor-Investigators and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Considerations When Transferring Clinical Investigation Oversight to Another IRB: Guidance for IRBs, Clinical Investigators, and Sponsors  Food and Drug Administration (FDA) Final
Frequently Asked Questions About Medical Devices: Guidance For IRBs, Clinical Investigators, and Sponsors  Food and Drug Administration (FDA) Final
Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors  Food and Drug Administration (FDA) Final
IRB Continuing Review After Clinical Investigation Approval: Guidance for IRBs, Clinical Investigators, and Sponsors  Food and Drug Administration (FDA) Final
IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed: Guidance for IRBs, Clinical Investigators, and Sponsors  Food and Drug Administration (FDA) Final
Significant Risk and Nonsignificant Risk Medical Device Studies: Guidance For IRBs, Clinical Investigators, and Sponsors  Food and Drug Administration (FDA) Final
Policy for Monkeypox Tests to Address the Public Health Emergency: Guidance for Laboratories, Commercial Manufacturers and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4033 documents.