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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date Sort descending
Evaluation of Sex-Specific and Gender-Specific Data in Medical Device Clinical Studies: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Updates to Billing for Care Coordination Services for Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs)  Centers for Medicare & Medicaid Services (CMS) Final
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Medical Purposes - Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Developing Drugs for Optical Imaging  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Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
CVM GFI #187B Heritable Intentional Genomic Alterations in Animals: The Approval Process  Food and Drug Administration (FDA) Final
CVM GFI #294 - Animal Food Ingredient Consultation (AFIC)  Food and Drug Administration (FDA) Final
Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Draft Calendar Year 2026 Part D Redesign Program Instructions G  Centers for Medicare & Medicaid Services (CMS) Final
Annual Request for Part D Payment Reconciliation Contact Information 2025 G  Centers for Medicare & Medicaid Services (CMS) Final
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