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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Sort ascending Issue Date
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Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Evaluation of Sex-Specific and Gender-Specific Data in Medical Device Clinical Studies: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products: Draft Guidance for Industry and Other Interested Parties  Food and Drug Administration (FDA) Proposed
Developing Drugs for Optical Imaging  Food and Drug Administration (FDA) Proposed
Obesity and Overweight: Developing Drugs and Biological Products for Weight Reduction  Food and Drug Administration (FDA) Proposed
Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Prevention and Treatment of Chemotherapy-Induced Peripheral Neuropathy: Developing Drug and Biological Products in Oncology  Food and Drug Administration (FDA) Proposed
Medicaid Program: Reassignment of Medicaid Provider Claims (CMS-2444-P)  Centers for Medicare & Medicaid Services (CMS) Proposed
Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements: Delay o  Centers for Medicare & Medicaid Services (CMS) Proposed
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