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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
Medicare Advantage Prescription Drug System July 2025 Payment INFORMATION G  Centers for Medicare & Medicaid Services (CMS) Final
Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases – Questions and Answers: Guidance for Industry  Food and Drug Administration (FDA) Final
Early Lyme Disease as Manifested by Erythema Migrans: Developing Drugs for Treatment  Food and Drug Administration (FDA) Final
Protecting Children from Lead Paint  Administration for Children and Families (ACF) Final
International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determinations (NCDs)—July 2025  Centers for Medicare & Medicaid Services (CMS) Final
Unique Device Identifier Requirements for Combination Products: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Updates to Chapter 1 of the Medicare Claims Processing Manual (Publication (Pub.) 100-04) to Include Newly Created and Utilized Payer Only Codes  Centers for Medicare & Medicaid Services (CMS) Final
Conducting Remote Regulatory Assessments Questions and Answers: Guidance for Industry  Food and Drug Administration (FDA) Final
April Quarterly Update for 2025 Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Fee Schedule  Centers for Medicare & Medicaid Services (CMS) Final
This Guidance Portal contains 4741 documents.