⚗️FDA Classifies Clinical Mass Spectrometry Devices
The Food and Drug Administration (FDA, the Agency, or we) is classifying the clinical mass spectrometry microorganism identification and differentiation system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the clinical mass spectrometry microorganism identification and differentiation system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Learn More🩺FDA Class II Medical Device Classification for Chronic Wound Care
The Food and Drug Administration (FDA, the Agency, or we) is classifying the device to detect bacterial protease activity in chronic wound fluid into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the device to detect bacterial protease activity in chronic wound fluid's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices in part by reducing regulatory burdens.
Learn More🩻FDA Classifies Radiological Devices to Enhance Market Access
The Food and Drug Administration (FDA, the Agency, or we) is classifying the radiological acquisition and/or optimization guidance system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the radiological acquisition and/or optimization guidance system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices in part by reducing regulatory burdens.
Learn More🍖FDA Confirms Myoglobin Color Additive Regulations for 2025
The Food and Drug Administration (FDA or we) is confirming the effective date of February 19, 2025, for the final order that appeared in the Federal Register of January 17, 2025. The final order amends the color additive regulations to provide for the safe use of myoglobin as a color additive in ground meat and ground poultry analogue products.
Learn More🌸FDA Expands Use of Butterfly Pea Flower Extract as Food Color Additive
The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the expanded safe use of butterfly pea flower extract as a color additive in ready-to-eat cereals, crackers, snack mixes, hard pretzels, plain potato chips (restructured or baked), and plain corn chips, tortilla chips, and multigrain chips at levels consistent with good manufacturing practice (GMP). This action is in response to a color additive petition (CAP) submitted by Sensient Colors, LLC (Sensient or petitioner).
Learn More🐾FDA Final Rule on New Animal Drug Regulations Effective May 2025
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), and conditionally approved new animal drug applications (CNADAs) during January, February, and March 2025. The animal drug regulations are also being amended to improve their accuracy and readability.
Learn More🥗FDA Delays Effective Date of "Healthy" Food Labeling Regulation
In accordance with the memorandum of January 20, 2025, from the President, entitled "Regulatory Freeze Pending Review," the effective date of the final rule entitled "Food Labeling: Nutrient Content Claims; Definition of Term `Healthy,' " is delayed until April 28, 2025.
Learn More🐾New Animal Drug Regulations Affecting Compliance and Approval Processes
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during October, November, and December 2024. The animal drug regulations are also being amended to improve their accuracy and readability.
Learn More🥩FDA Regulation on Myoglobin as Color Additive for Meat Alternatives
The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of myoglobin as a color additive in ground meat and ground poultry analogue products. We are taking this action in response to a color additive petition (CAP) submitted by Motif FoodWorks, Inc. (Motif FoodWorks or petitioner).
Learn More📊New FDA Food Labeling Rules
The Food and Drug Administration (FDA or we) proposes to require front-of-package nutrition labels on most foods that must bear a Nutrition Facts label. This action, if finalized, would require the display of a compact informational box containing certain nutrient information on the principal display panel. The box would provide consumers, including those who have lower nutrition knowledge, with standardized, interpretive nutrition information that can help them quickly and easily identify how foods can be part of a healthy diet. We also propose to amend certain nutrient content claim regulations to align with current nutrition science and avoid within-label inconsistencies.
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