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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date Sort ascending
Bioresearch Monitoring Technical Conformance Guide  Food and Drug Administration (FDA) Final
Guidelines for Achieving Compliance with Medicaid and CHIP Eligibility Renewal Timeliness Requirements Following the Medicaid and CHIP Unwinding Period  Centers for Medicare & Medicaid Services (CMS) Final
Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
CVM GFI #64 (VICH GL2) Validation of Analytical Procedures: Methodology  Food and Drug Administration (FDA) Final
CVM GFI #63 (VICH GL1) Validation of Analytical Procedures: Definition and Terminology  Food and Drug Administration (FDA) Final
Mammography Quality Standards Act and Regulation Amendments: Small Entity Compliance Guide: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Electronic Submission Template for Medical Device De Novo Requests: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Predetermined Change Control Plans for Medical Devices: Draft Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Proposed
Budget Neutrality for Section 1115(a) Medicaid Demonstration Projects SMDL (SMD 24-003)  Centers for Medicare & Medicaid Services (CMS) Final
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