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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date Sort ascending
Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program: - Final Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Updated 2025 SSI and Spousal Impoverishment Standards  Centers for Medicare & Medicaid Services (CMS) Final
Data Reporting Compliance for the Transformed-Medicaid Statistical Information System (T-MSIS)  Centers for Medicare & Medicaid Services (CMS) Final
Medicaid Program; Preserving Medicaid Funding for Vulnerable Populations – Closing a Health Care-Related Tax Loophole Proposed Rule  Centers for Medicare & Medicaid Services (CMS) Final
Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Recommendations to Reduce the Risk of Transmission of Mycobacterium tuberculosis (Mtb) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Evaluation of Sex-Specific Data in Medical Device Clinical Studies - 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
Data Standards Catalog  Food and Drug Administration (FDA) Final
Rescission of Guidance on Health-Related Social Needs  Centers for Medicare & Medicaid Services (CMS) Final
This Guidance Portal contains 3294 documents.

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