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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
Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Technical Considerations for Demonstrating Reliability of Emergency-Use Injectors Submitted under a BLA, NDA or ANDA: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation: Guidance for Industry and Food and Drug Administration Staff, And Other Stakeholders  Food and Drug Administration (FDA) Final
Guidance Document for Premarket Notification Submissions for Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer and Nitrogen Dioxide Analyzer: Guidance for Industry and for FDA Reviewers  Food and Drug Administration (FDA) Final
Meetings with Industry and Investigators on the Research and Development of Tobacco Products (Revised): Guidance for Industry and Investigators  Food and Drug Administration (FDA) Final
Safety Reporting Requirements for INDs (Investigational New Drug Applications) and BA/BE (Bioavailability/Bioequivalence) Studies: Guidance for Industry and Investigators  Food and Drug Administration (FDA) Final
Safety Reporting Requirements for INDs and BA/BE Studies: Guidance for Industry and Investigators  Food and Drug Administration (FDA) Final
Use of Investigational Tobacco Products: Draft Guidance for Industry and Investigators  Food and Drug Administration (FDA) Proposed
Emergency Use Authorization of Medical Products and Related Authorities: Guidance for Industry and Other Stakeholders  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.