The Food and Drug Administration (FDA or we) is proposing to issue an order that would repeal the color additive regulation that allows for the use of Citrus Red No. 2 for coloring the skins of mature oranges. Based on certification data, it appears that Citrus Red No. 2 is no longer used for coloring the skins of oranges and has not been certified for use as a color additive in food marketed in the United States since 2020. Because the authorized use of Citrus Red No. 2 appears to have been abandoned, we have tentatively concluded that this color additive regulation is outdated and unnecessary.
Comments close Aug 24, 2026
The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend the drug establishment registration and drug listing requirements with respect to establishments engaged in distributed manufacturing and foreign drug establishments. This action, if finalized, will provide a pathway for a distributed manufacturing establishment that manufactures drugs at multiple different physical locations to register as a single drug manufacturing establishment and align drug establishment registration and drug listing regulations applicable to foreign drug establishments with statutory changes made by the Preparing for and Responding to Existing Viruses, Emerging New Threats, and Pandemics Act (PREVENT Pandemics Act).
Comments close Sep 11, 2026
The Food and Drug Administration (FDA, the Agency, or we) is proposing regulations to prescribe the format, content, and procedures for establishment registration and tobacco product listing. Complete and accurate establishment registration and product listing information is important to accomplish statutory, regulatory, and public health objectives. Currently, only domestic owners and operators are required to register their establishments and list their tobacco products with FDA while foreign owners and operators are not subject to these requirements, creating significant gaps in Agency information. This action, if finalized, would extend registration and listing requirements to include owners and operators of foreign establishments.
Comments close Sep 14, 2026
The Food and Drug Administration (FDA or we) is reopening the comment period for the notification of petition, published in the Federal Register of January 11, 2024, announcing that we filed a food additive petition proposing that the food additive regulations be amended to remove four specified solvents. FDA is reopening the comment period to allow for the submission of any updated data and other information over the last two years.
Comments close Jun 29, 2026
The Food and Drug Administration (FDA or we) is reopening the comment period for the notification of petition, published in the Federal Register of January 11, 2024, announcing that we filed a color additive petition proposing that the color additive regulations be amended to remove three specified solvents. FDA is reopening the comment period to allow for the submission of any updated data and other information over the last two years.
Comments close Jun 29, 2026
The Food and Drug Administration (FDA, the Agency, or we) is issuing a proposed rule to modify certain terminology in Title 21 of the Code of Federal Regulations (CFR) to comply with Executive Order (E.O.) 14168, "Defending Women From Gender Ideology Extremism and Restoring Biological Truth to the Federal Government," issued on January 20, 2025. Specifically, this proposed rule, if finalized, will remove the term "gender" wherever it appears and either replace it with the term "sex," or delete reference to gender, as applicable, along with other editorial changes to improve readability.
Comments close Jul 6, 2026
The Food and Drug Administration (FDA or we) is announcing that we have filed a color additive petition, submitted by the International Association of Color Manufacturers (IACM or petitioner), proposing that we amend the color additive regulations to no longer provide for the use of three specified solvents (methylene chloride, trichloroethylene, and ethylene dichloride) for preparing certain color additives because these uses have been permanently abandoned.
Comments close Jun 1, 2026
The Food and Drug Administration (FDA) is proposing to reclassify Mycobacterium tuberculosis cell-mediated immunity tests and Mycobacterium tuberculosis cell-mediated immune response enzyme-linked immunospot tests intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection (product codes NCD and OJN, respectively), both of which are postamendments class III devices (premarket approval), into class II (special controls), subject to premarket notification. FDA is also proposing a new device classification regulation along with the special controls that FDA believes are necessary to provide a reasonable assurance of safety and effectiveness for these devices.
Comments close May 29, 2026
The Food and Drug Administration (FDA) is proposing to require the filing of a premarket approval application (PMA) for blood irradiators intended to irradiate intraoperatively salvaged blood for cancer patients undergoing surgery to assist in prevention of metastasis, which are unclassified, preamendments devices. FDA is summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the devices to meet PMA requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the benefits to the public from use of the devices.
Comments close May 18, 2026
The Food and Drug Administration (FDA) is proposing to classify blood irradiator devices (product code MOT), unclassified preamendments devices, as follows: blood irradiator devices intended to prevent transfusion-associated graft-versus-host disease into class II (special controls) with premarket notification and blood irradiator devices intended to prevent metastasis into class III (premarket approval) to provide a reasonable assurance of safety and effectiveness of these devices. Elsewhere in this issue of the Federal Register, FDA is issuing a proposed order proposing to require the filing of a premarket approval application for blood irradiator devices intended to prevent metastasis.
Comments close May 18, 2026
The Food and Drug Administration (FDA or we) is announcing that we have filed a food additive petition, submitted by Kemin Industries, Inc., proposing that we amend our food additive regulations to provide for the safe use of chromium propionate as a source of chromium in food for layer and breeding chickens.
Comments close Apr 3, 2026
The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the expanded use of spirulina (Arthrospira platensis) extract as a color additive in human foods generally (except for infant formula, certain foods subject to regulation by the U.S. Department of Agriculture, and foods for which standards of identity have been issued under section 401 of the Federal Food, Drug, and Cosmetic Act, unless the use of the added color is authorized by such standards) at levels consistent with good manufacturing practice (GMP), to lower the heavy metal specifications for lead, arsenic, and mercury, and to add a specification for cadmium. We are taking this action in response to a color additive petition (CAP) submitted by GNT USA, LLC (GNT or petitioner).
Comments close Mar 9, 2026
The Food and Drug Administration (FDA) is proposing to reclassify certain postamendments class III nucleic acid-based test systems indicated for use with a corresponding approved oncology therapeutic product (product codes OWD, PJG, PQP, and SFL) from class III (premarket approval) into class II (special controls), subject to premarket notification. FDA is also proposing a new device classification regulation, along with the special controls that FDA believes are necessary to provide a reasonable assurance of safety and effectiveness for these devices.
Comments close Jan 26, 2026
The Food and Drug Administration (FDA or we) is proposing to issue an order that would remove the color additive regulation that allows for the use of Orange B for coloring the casings or surfaces of frankfurters and sausages. Based on certification data, it appears that Orange B is no longer used for coloring the casings or surfaces of frankfurters and sausages and has not been certified for use as a color additive in food marketed in the United States since 1978. Because the authorized use of Orange B appears to have been abandoned, we have tentatively concluded that this color additive regulation is outdated and unnecessary.
Comments close Oct 17, 2025
The Food and Drug Administration (FDA or we) is amending the food additive regulation to provide for the safe use of hydrogen peroxide in food as an antimicrobial agent, oxidizing and reducing agent, and bleaching agent, and to remove sulfur dioxide. We are taking this action in response to a food additive petition filed by Cargill, Inc. (Cargill or petitioner).
Comments close Oct 3, 2025
The Food and Drug Administration is proposing to extend the compliance date for the final rule, "Requirements for Additional Traceability Records for Certain Foods," due to concerns about the amount of time affected entities will need to implement the requirements of the rule. If finalized, this rule would extend the compliance date by 30 months from January 20, 2026, to July 20, 2028.
Comments close Sep 8, 2025
The Food and Drug Administration (FDA or we) is proposing to amend the standard of identity for pasteurized orange juice (POJ) by lowering the minimum orange juice soluble solids content from 10.5[deg] to 10[deg] Brix. We tentatively conclude that this proposed amendment will promote honesty and fair dealing in the interest of consumers and provide industry greater flexibility in the manufacture of pasteurized orange juice. This action, if finalized, will respond to a citizen petition submitted by the Florida Citrus Processors Association Inc. and Florida Citrus Mutual Inc.
Comments close Nov 4, 2025
The Food and Drug Administration (FDA or we) is proposing to revoke 18 standards of identity for dairy products. FDA is taking this action as we tentatively conclude that these standards are no longer necessary to promote honesty and fair dealing in the interest of consumers. This proposed action would reduce redundant regulatory requirements.
Comments close Sep 15, 2025
The Food and Drug Administration (FDA or we) is proposing to revoke 11 food standards for foods that are no longer sold in the United States. FDA is taking this action as we tentatively conclude these standards are no longer necessary to promote honesty and fair dealing in the interest of consumers. This action, if finalized, will remove obsolete rules to possibly reduce unnecessary regulatory requirements.
Comments close Aug 18, 2025
The Food and Drug Administration (FDA or we) revokes 11 food standards for foods that are no longer sold in the United States. FDA is taking this action as these standards are no longer necessary to promote honesty and fair dealing in the interest of consumers. This action will remove obsolete rules to reduce unnecessary regulatory requirements.
Comments close Aug 18, 2025
The Food and Drug Administration (FDA or we) is proposing to revoke 23 standards of identity for food. FDA is taking this action because we tentatively conclude that these standards are no longer necessary to promote honesty and fair dealing in the interest of consumers. This proposed action would reduce redundant regulatory requirements.
Comments close Sep 15, 2025
The Food and Drug Administration (FDA) is proposing to reclassify in situ hybridization (ISH) test systems indicated for use with a corresponding approved oncology therapeutic product (product codes NYQ, MVD, OWE, and PNK) from class III (premarket approval) into class II (special controls), subject to premarket notification. FDA is also proposing a new device classification regulation, along with the special controls that FDA believes are necessary to provide a reasonable assurance of safety and effectiveness for this device type.
Comments close Aug 11, 2025
The Food and Drug Administration (FDA or we) is reopening the comment period for a draft guidance entitled "Establishing Sanitation Programs for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event: Guidance for Industry," which was announced in the Federal Register of January 7, 2025. We are taking this action in response to requests to allow interested persons additional time to submit comments before FDA begins work on the final guidance.
Comments close Jul 28, 2025
The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of zinc L- selenomethionine as a source of selenium in complete feed for broiler chickens. This action is in response to a food additive petition filed by Zinpro Corp.
Comments close Jun 18, 2025
The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of galdieria extract blue, derived from unicellular red algae (Galdieria sulphuraria), in various food categories at levels consistent with good manufacturing practice (GMP). We are taking this action in response to a color additive petition (CAP) submitted by Fermentalg (Fermentalg or petitioner).
Comments close Jun 11, 2025
The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of calcium phosphate as a color additive in ready-to-eat chicken products, white candy melts, doughnut sugar, and sugar for coated candies. This action is in response to a color additive petition (CAP) filed by Innophos, Inc. (Innophos or petitioner).
Comments close Jun 11, 2025
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).
Comments close Jun 11, 2025
The Food and Drug Administration (FDA or we) is extending the comment period for the proposed rule entitled "Food Labeling: Front- of-Package Nutrition Information" that appeared in the Federal Register of January 16, 2025. We are taking this action in response to requests for an extension to allow interested parties additional time to submit comments.
Comments close Jul 15, 2025
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).
Comments close Feb 18, 2025
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.
Comments close May 16, 2025
The Food and Drug Administration (FDA, the Agency, or we) is proposing a tobacco product standard that would regulate nicotine yield by establishing a maximum nicotine level in cigarettes and certain other combusted tobacco products. FDA is proposing this action to reduce the addictiveness of these products, thus giving people who are addicted and wish to quit the ability to do so more easily. The proposed product standard is anticipated to benefit the population as a whole. For example, it would help to prevent people who experiment with cigarettes and cigars from developing addiction and using combusted tobacco products regularly.
Comments close Sep 15, 2025
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry entitled "Establishing Sanitation Programs for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event." The draft guidance, when finalized, will explain FDA's current thinking on establishing a routine sanitation program for low-moisture ready-to-eat human foods (LMRTE foods) that can help prevent contamination of food or a food-contact surface with a pathogen and will explain our current thinking for corrective actions, including corrective actions to remediate contamination of food-contact surfaces, if prevention fails.
Comments close May 7, 2025
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Considerations for Complying With 21 CFR 211.110." This guidance, when finalized, will describe considerations for complying with the requirements for ensuring batch uniformity and drug product integrity. In addition, this guidance discusses related quality considerations for drug products that are manufactured using advanced manufacturing. FDA is committed to supporting and enabling pharmaceutical innovation and modernization as part of the Agency's mission to protect and promote the public health. FDA encourages industry representatives and manufactures who are interested in using innovative control strategies to contact the Agency.
Comments close Apr 7, 2025
The Food and Drug Administration (FDA) is classifying the phase-changing fiducial marker for radiation therapy 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 classification of the phase-changing fiducial marker for radiation therapy. We are taking this action because we have determined that classifying the device into class II 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.
The Food and Drug Administration (FDA) is classifying the active noise attenuation system for infant incubators 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 classification of the active noise attenuation system for infant incubators. We are taking this action because we have determined that classifying the device into class II 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.
The Food and Drug Administration (FDA) is classifying the non- medicated topical formulation for treatment of erectile dysfunction 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 classification of the non-medicated topical formulation for treatment of erectile dysfunction. We are taking this action because we have determined that classifying the device into class II 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.
The Food and Drug Administration (FDA or we) is announcing that we have filed a food additive petition, submitted by Evonik Corporation, proposing that we amend our food additive regulations to provide for the safe use of ethyl cellulose as a binder and coating on amino acids incorporated into food for ruminant animals.
The Food and Drug Administration (FDA) is classifying the intraoperative surgical angle measurement tool 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 classification of the intraoperative surgical angle measurement tool. We are taking this action because we have determined that classifying the device into class II 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.
The Food and Drug Administration (FDA) is classifying the diabetes digital behavioral therapeutic device 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 classification of the diabetes digital behavioral therapeutic device. We are taking this action because we have determined that classifying the device into class II 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.
The Food and Drug Administration (FDA) is classifying the over-the-counter test to detect SARS-CoV-2 from clinical specimens 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 classification of the over-the-counter test to detect SARS-CoV-2 from clinical specimens. We are taking this action because we have determined that classifying the device into class II 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.
The Food and Drug Administration (FDA) is classifying the prognostic test for assessment of chronic kidney disease progression 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 classification of the prognostic test for assessment of chronic kidney disease progression. We are taking this action because we have determined that classifying the device into class II 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.
The Food and Drug Administration (FDA or we) is issuing an order to repeal the color additive regulation that allows for the use of Orange B for coloring the casings or surfaces of frankfurters and sausages. We have determined that the authorized use of Orange B has been abandoned, and we have concluded that this color additive regulation is outdated and unnecessary. Therefore, FDA is revoking the authorized use in food of Orange B in the color additive regulations.
The Food and Drug Administration (FDA or we) is issuing a final rule to amend the standard of identity for pasteurized orange juice by lowering the minimum orange juice soluble solids content from 10.5[deg] to 10[deg] Brix and permitting up to 15 percent Citrus reticulata juice or Citrus reticulata hybrid juice, by volume. This final rule modernizes the pasteurized orange juice standard. This action responds to two citizen petitions: one submitted by the Florida Citrus Processors Association Inc. and the Florida Citrus Mutual Inc., and another submitted by the Florida Department of Citrus, the Florida Citrus Mutual, and the Juice Products Association.
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 2026. The animal drug regulations are also being amended to improve their accuracy and readability.
The Food and Drug Administration (FDA) is classifying the monitor for opioid induced impairment of oxygenation 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 classification of the monitor for opioid induced impairment of oxygenation. We are taking this action because we have determined that classifying the device into class II 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.
The Food and Drug Administration (FDA) is classifying the skin patch for treatment of hyperhidrosis 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 classification of the skin patch for treatment of hyperhidrosis. We are taking this action because we have determined that classifying the device into class II 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.
The Food and Drug Administration (FDA) is classifying the medial knee implanted shock absorber 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 classification of the medial knee implanted shock absorber. We are taking this action because we have determined that classifying the device into class II 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.
The Food and Drug Administration (FDA) is classifying the infant supine sleep 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 classification of the infant supine sleep system. We are taking this action because we have determined that classifying the device into class II 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.
The Food and Drug Administration (FDA) is classifying the external lower extremity nerve stimulator for Restless Legs Syndrome 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 classification of the external lower extremity nerve stimulator for Restless Legs Syndrome. We are taking this action because we have determined that classifying the device into class II 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.
The Food and Drug Administration (FDA) is classifying the breast implant suction retrieval 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 classification of the breast implant suction retrieval system. We are taking this action because we have determined that classifying the device into class II 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.
The Food and Drug Administration (FDA) is classifying the SARS-CoV-2 serology test 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 classification of the SARS- CoV-2 serology test. We are taking this action because we have determined that classifying the device into class II 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.
The Food and Drug Administration (FDA) is classifying the computerized behavioral therapy device for the treatment of fibromyalgia symptoms 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 classification of the computerized behavioral therapy device for the treatment of fibromyalgia symptoms. We are taking this action because we have determined that classifying the device into class II 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.
The Food and Drug Administration (FDA) is classifying the prognostic test for development or progression of preeclampsia 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 classification of the prognostic test for development or progression of preeclampsia. We are taking this action because we have determined that classifying the device into class II 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.
The Food and Drug Administration (FDA) is classifying the foam or gel chemical sterilant/high level disinfectant 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 classification of the foam or gel chemical sterilant/high level disinfectant. We are taking this action because we have determined that classifying the device into class II 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.
The Food and Drug Administration (FDA or we) is announcing that we have filed a food additive petition, submitted by Sterigenics U.S., LLC, proposing that we amend our food additive regulations to provide for the safe use of ionizing radiation for the reduction of pathogens in raw enriched wheat flour.
The Food and Drug Administration (FDA) is classifying the endoscopic traction device 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 classification of the endoscopic traction device. We are taking this action because we have determined that classifying the device into class II 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.
The Food and Drug Administration (FDA) is classifying the endoscopic light-projecting measuring device 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 classification of the endoscopic light-projecting measuring device. We are taking this action because we have determined that classifying the device into class II 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.
The Food and Drug Administration (FDA) is classifying the simple in vitro diagnostic device for the detection of secreted proteins from Bacillus species (spp.) in human clinical samples 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 classification of the simple in vitro diagnostic device for the detection of secreted proteins from Bacillus species (spp.) in human clinical samples. We are taking this action because we have determined that classifying the device into class II 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.
The Food and Drug Administration (FDA) is classifying the radiological machine learning-based quantitative imaging software with predetermined change control plan 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 classification of the radiological machine learning-based quantitative imaging software with predetermined change control plan. We are taking this action because we have determined that classifying the device into class II 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.
The Food and Drug Administration (FDA) is classifying the ingestible gastrointestinal blood detection capsule 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 classification of the ingestible gastrointestinal blood detection capsule. We are taking this action because we have determined that classifying the device into class II 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.
The Food and Drug Administration (FDA, the Agency, or we) is amending its regulations to direct the public to organizational and contact information available on the Agency's website. FDA is also revoking certain regulations that are no longer necessary in light of this amendment. These changes are appropriate to provide the public with a uniform source of Agency organizational and contact information that can be readily updated as needed in the future.
The Food and Drug Administration (FDA) is classifying the Spinal Muscular Atrophy newborn screening test 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 classification of the Spinal Muscular Atrophy newborn screening test system. We are taking this action because we have determined that classifying the device into class II 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.
The Food and Drug Administration (FDA) is classifying the simple point-of-care device to directly detect SARS-CoV-2 viral targets from clinical specimens in near-patient settings 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 classification of the simple point-of-care device to directly detect SARS-CoV-2 viral targets from clinical specimens in near-patient settings. We are taking this action because we have determined that classifying the device into class II 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.
The Food and Drug Administration (FDA) is classifying the combined acoustic and electrical external stimulation device for the relief of tinnitus 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 classification of the combined acoustic and electrical external stimulation device for the relief of tinnitus. We are taking this action because we have determined that classifying the device into class II 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.
The Food and Drug Administration (FDA) is classifying the resorbable calcium salt bone void filler containing a single approved aminoglycoside antibacterial into class II (special controls). The special controls that apply to the product type are identified in this order and will be part of the codified language for classification of the resorbable calcium salt bone void filler containing a single approved aminoglycoside antibacterial. We are taking this action because we have determined that classifying the product into class II will provide a reasonable assurance of safety and effectiveness of the product. We believe this action will also enhance patients' access to beneficial innovative products, in part by reducing regulatory burdens.
The Food and Drug Administration (FDA) is classifying the shoulder joint humeral (hemi-shoulder) ceramic head/metallic stem cemented or uncemented prosthesis 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 classification of the shoulder joint humeral (hemi-shoulder) ceramic head/metallic stem cemented or uncemented prosthesis. We are taking this action because we have determined that classifying the device into class II 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.
The Food and Drug Administration (FDA) is classifying the absorbable metallic bone fixation fastener 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 classification of the absorbable metallic bone fixation fastener. We are taking this action because we have determined that classifying the device into class II 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.
The Food and Drug Administration (FDA or we) is amending the final rule that published in the Federal Register of April 16, 2026. That final rule updated regulations to reflect application-related actions for new animal drug applications and abbreviated new animal drug applications during October, November, and December of 2025. The final rule published with some inadvertent errors in the instructions for technical amendments. This document corrects those errors.
The Food and Drug Administration (FDA) is classifying the rigid sterilization container with electronic monitoring 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 classification of the rigid sterilization container with electronic monitoring. We are taking this action because we have determined that classifying the device into class II 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.
The Food and Drug Administration (FDA) is classifying the real-time ultrasound anatomy visualization and labeling device for ultrasound guided regional anesthesia 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 classification of the real-time ultrasound anatomy visualization and labeling device for ultrasound guided regional anesthesia. We are taking this action because we have determined that classifying the device into class II 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.
The Food and Drug Administration (FDA) is classifying the adjunctive pain measurement device for anesthesiology 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 classification of the adjunctive pain measurement device for anesthesiology. We are taking this action because we have determined that classifying the device into class II 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.
The Food and Drug Administration (FDA) is classifying the orally ingested transient device for constipation 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 classification of the orally ingested transient device for constipation. We are taking this action because we have determined that classifying the device into class II 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.
The Food and Drug Administration (FDA) is classifying the intraoral cooling device 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 classification of the intraoral cooling device. We are taking this action because we have determined that classifying the device into class II 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.
The Food and Drug Administration (FDA) is classifying the von Willebrand factor assay 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 classification of the von Willebrand factor assay. We are taking this action because we have determined that classifying the device into class II 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.
The Food and Drug Administration (FDA) is classifying the oropharyngeal electrical stimulator 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 classification of the oropharyngeal electrical stimulator. We are taking this action because we have determined that classifying the device into class II 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.
The Food and Drug Administration (FDA) is classifying the transcutaneous electrical nerve stimulator to treat fibromyalgia symptoms 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 classification of the transcutaneous electrical nerve stimulator to treat fibromyalgia symptoms. We are taking this action because we have determined that classifying the device into class II 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.
The Food and Drug Administration (FDA) is classifying the endoscopic suturing device for altering gastric anatomy for weight loss 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 classification of the endoscopic suturing device for altering gastric anatomy for weight loss. We are taking this action because we have determined that classifying the device into class II 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.
The Food and Drug Administration (FDA) is classifying the device to detect and identify microorganism nucleic acids and resistance markers from patients with suspected orthopedic infection 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 classification of the device to detect and identify microorganism nucleic acids and resistance markers from patients with suspected orthopedic infection. We are taking this action because we have determined that classifying the device into class II 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.
The Food and Drug Administration (FDA) is classifying the external condom for anal intercourse or vaginal intercourse 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 classification of the external condom for anal intercourse or vaginal intercourse. We are taking this action because we have determined that classifying the device into class II 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.
The Food and Drug Administration (FDA) is classifying the corneal storage medium with preservatives including antifungals 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 classification of the corneal storage medium with preservatives including antifungals. We are taking this action because we have determined that classifying the device into class II 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.
The Food and Drug Administration (FDA) is classifying the circulating tumor cell enrichment device 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 classification of the circulating tumor cell enrichment device. We are taking this action because we have determined that classifying the device into class II 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.
The Food and Drug Administration (FDA) is classifying the device to preserve and stabilize relative abundances of microbial nucleic acids in clinical samples 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 classification of the device to preserve and stabilize relative abundances of microbial nucleic acids in clinical samples. We are taking this action because we have determined that classifying the device into class II 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.
The Food and Drug Administration (FDA) is classifying the phototherapy device for reducing the appearance of acute post-surgical incisions 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 classification of the phototherapy device for reducing the appearance of acute post-surgical incisions. We are taking this action because we have determined that classifying the device into class II 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.
The Food and Drug Administration (FDA) is classifying the laser-powered inferior vena cava filter retrieval catheter 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 classification of the laser-powered inferior vena cava filter retrieval catheter. We are taking this action because we have determined that classifying the device into class II 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.
The Food and Drug Administration (FDA) is classifying the brain temperature measurement 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 classification of the brain temperature measurement system. We are taking this action because we have determined that classifying the device into class II 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.
The Food and Drug Administration (FDA) is classifying the radiation therapy marking device 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 classification of the radiation therapy marking device. We are taking this action because we have determined that classifying the device into class II 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.
The Food and Drug Administration (FDA, the Agency, or we) is classifying the setmelanotide eligibility gene variant detection 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 classification of the setmelanotide eligibility gene variant detection system. We are taking this action because we have determined that classifying the device into class II 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.
The Food and Drug Administration (FDA) is classifying the device for sleep apnea testing based on mandibular movement 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 classification of the device for sleep apnea testing based on mandibular movement. We are taking this action because we have determined that classifying the device into class II 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.
The Food and Drug Administration (FDA, the Agency, or we) is classifying the digital therapy device for amblyopia 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 classification of the digital therapy device for amblyopia. We are taking this action because we have determined that classifying the device into class II 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.
The Food and Drug Administration (FDA, the Agency, or we) is classifying the Alzheimer's disease pathology assessment test 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 classification of the Alzheimer's disease pathology assessment test. We are taking this action because we have determined that classifying the device into class II 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.
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 October, November, and December 2025. The animal drug regulations are also being amended to improve their accuracy and readability.
The Food and Drug Administration (FDA, the Agency, or we) is classifying the manual surgical instrument for appropriate patient selection for orthopedic implant 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 classification of the manual surgical instrument for appropriate patient selection for orthopedic implant. We are taking this action because we have determined that classifying the device into class II 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.
The Food and Drug Administration (FDA) is issuing a final order to reclassify non-invasive bone growth stimulators (product codes LOF and LPQ), postamendments class III devices, into class II, subject to premarket notification. FDA is codifying the reclassification of these devices under the new classification regulation, "non-invasive bone growth stimulator." FDA is also establishing the special controls necessary to provide reasonable assurance of safety and effectiveness of these devices.
The Food and Drug Administration (FDA, the Agency, or we) is classifying the transcutaneous electrical nerve stimulator for the relief of congestion 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 classification of the transcutaneous electrical nerve stimulator for the relief of congestion. We are taking this action because we have determined that classifying the device into class II 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.
The Food and Drug Administration (FDA) is issuing a final order reclassifying optical diagnostic devices for melanoma detection (product code OYD) and electrical impedance spectrometers (product code ONV), both postamendments class III device types, into class II (special controls), subject to premarket notification. FDA is also renaming and codifying these devices under the new classification regulation named "software-aided adjunctive diagnostic devices for use on skin lesions by physicians trained in the diagnosis and management of skin cancer." FDA is also establishing the special controls necessary to provide a reasonable assurance of safety and effectiveness of these devices.
The Food and Drug Administration (FDA or we) is announcing a delay of the effective date of our February 6, 2026, final order to amend the color additive regulations to provide for the expanded safe use of spirulina (Arthrospira platensis) extract as a color additive in human foods generally (except for infant formula, certain foods subject to regulation by the U.S. Department of Agriculture (USDA), and foods for which standards of identity have been issued under section 401 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), unless the use of the added color is authorized by such standards) at levels consistent with good manufacturing practice (GMP); to lower the heavy metal specifications for lead, arsenic, and mercury; and to add a specification for cadmium. The delay of the effective date is required by law following the filing of timely objections and a request for a hearing on the final order. This announcement does not reflect a change in our determination that there is a reasonable certainty of no harm from the use of this color additive under the conditions of its intended use. In addition, this announcement does not constitute a determination that all of the issues raised in the submission constitute objections or that a hearing is justified on any objections or requests for a hearing that have been filed.
The Food and Drug Administration (FDA or we) is announcing a delay of the effective date of our February 6, 2026, final order to amend the color additive regulations to provide for the safe use of beetroot red for the coloring of human foods generally, at levels consistent with current good manufacturing practice, except in products under the jurisdiction of the United States Department of Agriculture (USDA), infant formula, or foods for which standards of identity have been issued under section 401 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), unless the use of the added color is authorized by such standards. The delay of the effective date is required by law following the filing of timely objections on the final order. This announcement does not reflect a change in our determination that there is a reasonable certainty of no harm from the use of this color additive under the conditions of its intended use. In addition, this announcement does not constitute a determination that all of the issues raised in the relevant submission constitute objections or that a hearing is justified on any objections that have been filed.
The Food and Drug Administration (FDA) is announcing the withdrawal of the proposed rule titled "General and Plastic Surgery Devices: Restricted Sale, Distribution, and Use of Sunlamp Products," which published in the Federal Register of December 22, 2015. FDA is taking this action because it no longer intends to finalize the proposed rule.
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to standardize the format of the National Drug Code (NDC). Under this final rule, all FDA-assigned NDCs will be required to be 12 digits in length with 3 distinct segments and 1 uniform format. The first segment is a 6-digit labeler code, the second segment is a 4-digit product code, and the third segment is a 2-digit package code. Additionally, we are revising the drug product barcode label requirements to permit the use of other data carriers that meet the standards of this final rule.
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Ecoflora Cares, c/o Exponent, Inc., proposing that we amend our color additive regulations to provide for the safe use of jagua (genipin-glycine) blue as a color additive in pet foods at levels consistent with good manufacturing practice.
