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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date Sort ascending
Transfer of a Premarket Notification (510(k)) Clearance – Questions and Answers: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
M11 Template: Clinical Electronic Structured Harmonised Protocol (CeSHarP)  Food and Drug Administration (FDA) Proposed
cib06052025  Centers for Medicare & Medicaid Services (CMS) Final
Recommendations for Complying With Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
CVM GFI #287 - Raw Data for Safety and Effectiveness Studies  Food and Drug Administration (FDA) Final
Deadlines for the Submission of Risk Adjustment Data for Risk Adjustment Data Validation Sampling G  Centers for Medicare & Medicaid Services (CMS) Final
M13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Medicare Advantage Prescription Drug System June 2025 Payment INFORMATION G  Centers for Medicare & Medicaid Services (CMS) Final
Electronic Submission Template for Medical Device Q-Submissions: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
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
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