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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status 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Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
CPG Sec. 665.100 Common or Usual Names for Animal Feed Ingredients (Withdrawn 1/6/2025)  Food and Drug Administration (FDA) Final
Guidance for Industry: Action Levels for Lead in Processed Food Intended for Babies and Young Children  Food and Drug Administration (FDA) Final
Draft Guidance for Industry: Establishing Sanitation Programs for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event  Food and Drug Administration (FDA) Proposed
Guidance for FDA Staff and Interested Parties: Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act  Food and Drug Administration (FDA) Final
Recommendations to Reduce the Risk of Transmission of Human Immunodeficiency Virus (HIV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed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of Mycobacterium tuberculosis (Mtb) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
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for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products: Draft Guidance for Industry and Other Interested Parties  Food and Drug Administration (FDA) Proposed
Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
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of Disease Agents Associated with Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 3359 documents.

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