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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date Sort ascending
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
Early Lyme Disease as Manifested by Erythema Migrans: Developing Drugs for Treatment  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
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Unique Device Identifier Requirements for Combination Products: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed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
Q1 Stability Testing of Drug Substances and Drug Products: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
July 2025 Integrated Outpatient Code Editor (I/OCE) Specifications Version 26.2  Centers for Medicare & Medicaid Services (CMS) Final
July 2025 Update of the Hospital Outpatient Prospective Payment System (OPPS)  Centers for Medicare & Medicaid Services (CMS) Final
This Guidance Portal contains 3298 documents.

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