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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
Decorative, Non-corrective Contact Lenses: Guidance for Industry, FDA Staff, Eye Care Professionals, and Consumers  Food and Drug Administration (FDA) Final
Frequently-Asked-Questions about the Reprocessing and Reuse of Single-Use Devices by Third-Party and Hospital Reprocessors - Three Additional Questions: Guidance for Industry, FDA Staff, Third-Party and Hospital Reprocessors  Food and Drug Administration (FDA) Final
Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle: Guidance for Industry, Food and Drug Administration Staff, and Other Interested Parties  Food and Drug Administration (FDA) Final
Patient Engagement in the Design and Conduct of Medical Device Clinical Studies: Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders  Food and Drug Administration (FDA) Final
Patient-Focused Drug Development: Methods to Identify What Is Important to Patients: Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders  Food and Drug Administration (FDA) Final
510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review: Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations  Food and Drug Administration (FDA) Final
Investigational IVDs Used in Clinical Investigations of Therapeutic Products: Draft Guidance for Industry, Food and Drug Administration Staff, Sponsors, and Institutional Review Boards  Food and Drug Administration (FDA) Proposed
Exploratory IND Studies: Guidance for Industry, Investigators, and Reviewers  Food and Drug Administration (FDA) Final
Cancer Clinical Trial Eligibility Criteria: Laboratory Values: Draft Guidance for Industry, IRBs, and Clinical Investigators  Food and Drug Administration (FDA) Proposed
Cancer Clinical Trial Eligibility Criteria: Performance Status: Draft Guidance for Industry, IRBs, and Clinical Investigators  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4036 documents.