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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
Policy for Coronavirus Disease-2019 Tests (Revised): Guidance for Developers and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Establishment and Operation of Clinical Trial Data Monitoring Committees: Guidance for Clinical Trial Sponsors  Food and Drug Administration (FDA) Final
Investigational New Drug Applications (INDs) - Determining Whether Human Research Studies Can Be Conducted Without an IND: Guidance for Clinical Investigators, Sponsors, and IRBs  Food and Drug Administration (FDA) Final
Adverse Event Reporting to IRBs — Improving Human Subject Protection: Guidance for Clinical Investigators, Sponsors, and IRBs  Food and Drug Administration (FDA) Final
Process for Handling Referrals to FDA Under 21 CFR 50.54 - Additional Safeguards for Children in Clinical Investigations: Guidance for Clinical Investigators, Institutional Review Boards and Sponsors  Food and Drug Administration (FDA) Final
Guidance on Medical Device Patient Labeling: Final Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Labeling Recommendations for Single-Use Devices Reprocessed by Third Parties and Hospitals: Final Guidance for Industry and FDA  Food and Drug Administration (FDA) Final
Frequently-Asked-Questions about the Reprocessing and Reuse of Single-Use Devices by Third-Party and Hospital Reprocessors: Final Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Voting Procedures for Advisory Committee Meetings: Guidance for FDA Advisory Committee Members and FDA Staff  Food and Drug Administration (FDA) Final
Potency Tests for Cellular and Gene Therapy Products: Final Guidance for Industry:  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.