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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
Pulse Oximeters for Medical Purposes - Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products: Draft Guidance for Industry and Other Interested Parties  Food and Drug Administration (FDA) Proposed
Developing Drugs for Optical Imaging  Food and Drug Administration (FDA) Proposed
Obesity and Overweight: Developing Drugs and Biological Products for Weight Reduction  Food and Drug Administration (FDA) Proposed
Premarket Approval Application and Humanitarian Device Exemption Modular Review: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Prevention and Treatment of Chemotherapy-Induced Peripheral Neuropathy: Developing Drug and Biological Products in Oncology  Food and Drug Administration (FDA) Proposed
Evaluation of Sex Differences in Clinical Investigations: Guidance for Industry  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4128 documents.