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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date Sort ascending
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Medical Purposes - Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Considerations for Including Tissue Biopsies in Clinical Trials  Food and Drug Administration (FDA) Proposed
Developing Drugs for Optical Imaging  Food and Drug Administration (FDA) Proposed
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
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Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
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for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products: Draft Guidance for Industry and Other Interested Parties  Food and Drug Administration (FDA) Proposed
CVM GFI #187B Heritable Intentional Genomic Alterations in Animals: The Approval Process  Food and Drug Administration (FDA) Final
CVM GFI #251 - Heritable Intentional Genomic Alterations in Animals of Food-Producing Species for Use as Models of Disease  Food and Drug Administration (FDA) Proposed
Obesity and Overweight: Developing Drugs and Biological Products for Weight Reduction  Food and Drug Administration (FDA) Proposed
Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 3298 documents.

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