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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
Medical Devices with Indications Associated with Weight Loss - Clinical Study and Benefit-Risk Considerations: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Medical Devices with Indications Associated with Weight Loss - Non-Clinical Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Patient-Matched Guides to Orthopedic Implants: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Over-the-Counter Monograph Order Requests: Format and Content  Food and Drug Administration (FDA) Proposed
Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program: Draft Guidance…  Food and Drug Administration (FDA) Proposed
Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments  Food and Drug Administration (FDA) Proposed
Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making  Food and Drug Administration (FDA) Proposed
Biocompatibility Testing of Medical Devices - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program : Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration…  Food and Drug Administration (FDA) Proposed
Osteoarthritis: Structural Endpoints for the Development of Drugs  Food and Drug Administration (FDA) Proposed
Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework Guidance for Industry  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4741 documents.