⚖️FDA Guidance on Sex-Specific Data in Medical Device Studies
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Evaluation of Sex- Specific and Gender-Specific Data in Medical Device Clinical Studies." This document provides guidance on the study and evaluation of sex- and/or gender-specific data in clinical investigations or research involving one or more subjects to determine the safety or effectiveness of a device. The purpose of this guidance is to encourage science- driven consideration of sex and/or gender, as appropriate for both the scientific question being addressed and the intended use of the device, when designing medical device clinical studies and reporting data from such studies in accordance with legal requirements. This draft guidance is not final nor is it for implementation at this time.
Learn More🩺FDA Draft Guidance on Reducing Disease Transmission Risks in HCT/Ps
The Food and Drug Administration (FDA or Agency) is announcing the availability of three specific draft guidances for industry entitled "Recommendations to Reduce the Risk of Transmission of Hepatitis B Virus (HBV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps);" "Recommendations to Reduce the Risk of Transmission of Hepatitis C Virus (HCV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps);" and "Recommendations to Reduce the Risk of Transmission of Human Immunodeficiency Virus (HIV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)." These draft guidances are intended to update existing guidances and to assist establishments making donor eligibility determinations in understanding the requirements for determining donor eligibility, including donor screening and testing, for donors of HCT/Ps. These draft guidances are also intended to provide establishments making donor eligibility determinations with recommendations to reduce the risk of transmission of specific communicable disease agents and diseases, specifically, hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV), by HCT/Ps.
Learn More🧬FDA Guidance on Heritable Genomic Alterations in Animals
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry #187B entitled "Heritable Intentional Genomic Alterations in Animals: The Approval Process." This guidance clarifies FDA's requirements and recommendations for developers of intentional genomic alterations (IGAs) in animals. The guidance is one of two companion documents. "Heritable Intentional Genomic Alterations in Animals: The Approval Process" describes how the FDA approval process applies to heritable IGAs in animals. The companion final guidance, GFI #187A entitled "Heritable Intentional Genomic Alterations in Animals: Risk-Based Approach," describes FDA's risk-based regulatory approach to the oversight of heritable IGAs in animals.
Learn More⚠️FDA Guidance to Reduce Sepsis Risk in Human Cells and Tissues
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance for immediate implementation entitled "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)." FDA is issuing this guidance to provide establishments making donor eligibility determinations with recommendations to reduce the risk of transmission of infections due to sepsis by HCT/Ps. This notice is being issued to respond to a public health safety concern and to address the urgent need for updated recommendations in making a donor eligibility determination when screening a donor for clinical evidence of sepsis and clinical signs to consider.
Learn More📄FDA Draft Guidance on AI-Enabled Device Software Functions
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Artificial Intelligence Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations." This draft guidance, when finalized, will provide recommendations regarding the contents of marketing submissions for devices that include artificial intelligence (AI)-enabled device software functions including documentation and information that will support FDA's evaluation of safety and effectiveness. To support the development of appropriate documentation for FDA's assessment of the device, this draft guidance also proposes recommendations for the design, development, and implementation of AI- enabled devices that sponsors may wish to consider using throughout the total product lifecycle (TPLC). This draft guidance is not final nor is it for implementation at this time.
Learn More📜FDA Guidance on Device Manufacturing Discontinuances and Notifications
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act." This guidance updates the previous version of the guidance, of the same title, issued on November 17, 2023, and finalizes the concurrently issued draft guidance entitled "Select Updates for the 506J Guidance: 506J Device List and Additional Notifications." This guidance finalizes a list of device product codes for which a manufacturer of such devices is required to notify FDA in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) (hereafter referred to as the "506J Device List") and clarifies that manufacturers may submit voluntary notifications regarding supply chain issues at any time, unrelated to the declaration or potential declaration of a public health emergency (PHE).
Learn More🌱FDA Guidance on Plant-Based Food Labeling and Compliance
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled "Labeling of Plant-Based Alternatives to Animal-Derived Foods." This draft guidance, when finalized, will provide our recommendations on best practices for naming and labeling of certain plant-based foods that are marketed and sold as alternatives for animal-derived foods (plant-based alternative foods), especially in the absence of a common or usual name for the product. This draft guidance does not address the naming and labeling of plant-based milk alternatives; FDA is providing recommendations regarding these products in a separate guidance document.
Learn More🏥FDA Issues Interim Guidance on Compounding Bulk Drug Substances
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act." This guidance describes FDA's interim regulatory policy concerning compounding by outsourcing facilities using bulk drug substances while FDA develops the list of bulk drug substances that outsourcing facilities can use in compounding under the applicable section of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance finalizes the draft guidance of the same title issued in December 2023 and replaces the final guidance of the same title issued in January 2017.
Learn More📋FDA Guidance on Accelerated Drug Approval and Confirmatory Trials
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway." For drugs granted accelerated approval, sponsors conduct confirmatory studies that must be completed postapproval to verify and describe the anticipated effect on irreversible morbidity or mortality or other clinical benefit. This draft guidance describes FDA's interpretation of the term "underway" and discusses policies for implementing this requirement, including factors FDA intends to consider when determining whether a confirmatory trial is underway prior to accelerated approval.
Learn More📊FDA Guidance on Analytical Testing Methods for Tobacco Products
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry entitled "Validation and Verification of Analytical Testing Methods Used for Tobacco Products." The guidance provides information and recommendations related to the validation and verification of analytical test methods, including analytical testing of tobacco product constituents, ingredients, and additives, as well as stability testing of tobacco products. This guidance is intended to help industry produce more consistent and reliable analytical data used to support regulatory submissions for finished tobacco products. This guidance finalizes the draft guidance of the same title issued in December 2021.
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