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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
Content of Human Factors Information in Medical Device Marketing Submissions: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Study Data Technical Conformance Guide - Technical Specifications Document  Food and Drug Administration (FDA) Final
Interim Final Rule with Comment Period: Medicaid Program; Community Engagement Requirement for Certain Individuals (CMS-2454-IFC)  Centers for Medicare & Medicaid Services (CMS) Final
Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing  Food and Drug Administration (FDA) Proposed
Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
M15 General Principles for Model-Informed Drug Development  Food and Drug Administration (FDA) Final
Certain Postapproval Requirements and Resources for ANDAs  Food and Drug Administration (FDA) Final
Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Determining Eligibility for Title IV-E Kinship Guardianship Assistance Payments  Administration for Children and Families (ACF) Final
Instructions for State Courts on Applying for State Court Improvement Program (CIP) Funds for Fiscal Year (FY) 2027  Administration for Children and Families (ACF) Final
This Guidance Portal contains 4128 documents.