{"description":"Documents from Food and Drug Administration","count":10000,"total_pages":50,"next_page_url":"https://www.federalregister.gov/api/v1/documents?conditions%5Bagencies%5D%5B%5D=food-and-drug-administration&format=json&page=2&search_after_cursor=WzE3ODg5OTg0MDAwMDAsIjIwMjYtMTg0MjkiXQ","results":[{"title":"Electronic Submission Template for Medical Device Premarket Approval Applications (PMAs); Draft Guidance for Industry and Food and Drug Administration Staff; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled \"Electronic Submission Template for Medical Device Premarket Approval Applications (PMAs).\" FDA is issuing this draft guidance for submitters of certain PMAs to the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER). It introduces those submitters to the current publicly available resources and associated content developed to support electronic submissions of certain PMAs and PMA supplements to FDA. This draft guidance, when finalized, is intended to represent one of several steps in meeting FDA's commitment to the development of electronic submission templates to serve as guided submission preparation tools for industry to improve submission consistency and enhance efficiency in the review process. This draft guidance is not final nor is it for implementation at this time.","document_number":"2026-19181","html_url":"https://www.federalregister.gov/documents/2026/09/18/2026-19181/electronic-submission-template-for-medical-device-premarket-approval-applications-pmas-draft","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-09-18/pdf/2026-19181.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-19181.pdf?1789649121","publication_date":"2026-09-18","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled \"Electronic Submission Template for Medical Device Premarket Approval Applications (PMAs).\" FDA is issuing this draft guidance for submitters..."},{"title":"Biosimilar User Fee Act III Future Needs in the Development of Interchangeable Products Post-Workshop; Draft Strategy Document","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the publication of a draft strategy document titled \"BsUFA III Future Needs in the Development of Interchangeable Products Post-Workshop Strategy Document\" (Strategy Document). This draft Strategy Document is intended to summarize the discussion that occurred at the FDA public workshop, \"Advancing the Development of Interchangeable Products: Identifying Future Needs,\" held on September 19, 2025, and to describe FDA's future directions to support interchangeable biosimilar products. FDA is issuing this draft Strategy Document to fulfill a commitment FDA made in the Biosimilar User Fee Act (BsUFA) reauthorization commitment letter for fiscal years 2023 through 2027 (BsUFA III) to publish a post-workshop draft strategy document for public comment.","document_number":"2026-19166","html_url":"https://www.federalregister.gov/documents/2026/09/18/2026-19166/biosimilar-user-fee-act-iii-future-needs-in-the-development-of-interchangeable-products","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-09-18/pdf/2026-19166.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-19166.pdf?1789649120","publication_date":"2026-09-18","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"The Food and Drug Administration (FDA or Agency) is announcing the publication of a draft strategy document titled \"BsUFA III Future Needs in the Development of Interchangeable Products Post-Workshop Strategy Document\" (Strategy Document). This draft..."},{"title":"Target Animal Safety Evaluation for Veterinary Monoclonal Antibody Products; Draft Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #298 (VICH GL62) titled \"Target Animal Safety Evaluation for Veterinary Monoclonal Antibody Products.\" This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This draft guidance contributes to the international harmonization of methods used for the target animal safety (TAS) evaluation of veterinary monoclonal antibody products (VMAPs) and aids in preparing and conducting VMAP TAS studies under laboratory and field conditions. A harmonized standard is intended to aid in development of mutually acceptable VMAP TAS programs.","document_number":"2026-19141","html_url":"https://www.federalregister.gov/documents/2026/09/18/2026-19141/target-animal-safety-evaluation-for-veterinary-monoclonal-antibody-products-draft-guidance-for","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-09-18/pdf/2026-19141.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-19141.pdf?1789649115","publication_date":"2026-09-18","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #298 (VICH GL62) titled \"Target Animal Safety Evaluation for Veterinary Monoclonal Antibody Products.\" This draft guidance has been..."},{"title":"Recommendations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method; Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance titled \"Recommendations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method.\" The guidance document provides recommendations on the development of blood collection, processing, and storage systems (e.g., blood bags with anticoagulant and additive solutions, empty bags for platelet pooling) intended for the manufacture of blood and blood components for transfusion using the buffy coat (BC) method and on regulatory submissions to FDA for such products. This guidance is intended for manufacturers of blood collection, processing, and storage systems. The guidance announced in this notice finalizes the draft guidance of the same title dated October 18, 2024.","document_number":"2026-19080","html_url":"https://www.federalregister.gov/documents/2026/09/17/2026-19080/recommendations-for-the-development-of-blood-collection-processing-and-storage-systems-for-the","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-09-17/pdf/2026-19080.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-19080.pdf?1789562714","publication_date":"2026-09-17","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance titled \"Recommendations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy..."},{"title":"Medical Devices; Exemption From Premarket Notification: Radiology Computer-Aided Detection and/or Diagnosis Devices and Computer-Aided Triage and Notification Devices","type":"Rule","abstract":"The Food and Drug Administration (FDA) is publishing an order setting forth its final determination regarding a partial exemption from the premarket notification requirements for radiology computer- aided detection and/or diagnosis devices and computer-aided triage and notification devices that was the subject of a notice published in the Federal Register of December 29, 2025. That notice announced FDA's receipt of a petition that requested exemption from the premarket notification requirements for the following generic device types when certain conditions described in the petition were met: radiological computer-assisted diagnostic software for lesions suspicious of cancer; medical image analyzers; radiological computer aided triage and notification software; and radiological computer-assisted detection and diagnosis software. FDA denied the petition in a response issued to the petitioner on April 1, 2026. FDA is publishing this order in accordance with procedures established by the Federal Food, Drug, and Cosmetic Act (FD&C Act).","document_number":"2026-19074","html_url":"https://www.federalregister.gov/documents/2026/09/17/2026-19074/medical-devices-exemption-from-premarket-notification-radiology-computer-aided-detection-andor","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-09-17/pdf/2026-19074.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-19074.pdf?1789562713","publication_date":"2026-09-17","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"The Food and Drug Administration (FDA) is publishing an order setting forth its final determination regarding a partial exemption from the premarket notification requirements for radiology computer- aided detection and/or diagnosis devices and..."},{"title":"Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing","type":"Notice","abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.","document_number":"2026-18946","html_url":"https://www.federalregister.gov/documents/2026/09/16/2026-18946/agency-information-collection-activities-submission-for-office-of-management-and-budget-review","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-09-16/pdf/2026-18946.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-18946.pdf?1789476311","publication_date":"2026-09-16","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995."},{"title":"Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Pathogen-Agnostic Sequencing","type":"Notice","abstract":"The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Microbiology Devices Panel of the Medical Devices Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA. In addition, the Committee will meet to discuss and provide advice to FDA on examining the scientific, clinical, and public health dimensions of the use of pathogen-agnostic sequencing as it relates to emergency preparedness and response efforts, and to support discussion of opportunities, implementation considerations, and potential priorities for future coordination. The preparedness use could cover local and national outbreaks, known pathogens, or unknown pathogens. This meeting is being held to satisfy, in part, a requirement under the Food and Drug Omnibus Reform Act of 2022 (FDORA). The meeting will be open to the public. FDA is establishing a docket for public comment.","document_number":"2026-18920","html_url":"https://www.federalregister.gov/documents/2026/09/16/2026-18920/microbiology-devices-panel-of-the-medical-devices-advisory-committee-notice-of-meeting-establishment","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-09-16/pdf/2026-18920.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-18920.pdf?1789476308","publication_date":"2026-09-16","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Microbiology Devices Panel of the Medical Devices Advisory Committee (the Committee). The general function of the Committee is to provide advice and..."},{"title":"Statistical Considerations for the Design of Rare Disease Clinical Investigations; Establishment of a Public Docket; Request for Information and Comments","type":"Notice","abstract":"The Food and Drug Administration (FDA, the Agency, or we) is establishing a public docket to collect feedback on statistical considerations for rare disease clinical investigations. This docket is open in conjunction with a Rare disease Innovation, Science, and Exploration (RISE) Workshop on the same topic. Feedback is welcome both on the attached pre-read documents and on the content covered in the Workshop itself.","document_number":"2026-18805","html_url":"https://www.federalregister.gov/documents/2026/09/15/2026-18805/statistical-considerations-for-the-design-of-rare-disease-clinical-investigations-establishment-of-a","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-09-15/pdf/2026-18805.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-18805.pdf?1789389911","publication_date":"2026-09-15","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"The Food and Drug Administration (FDA, the Agency, or we) is establishing a public docket to collect feedback on statistical considerations for rare disease clinical investigations. This docket is open in conjunction with a Rare disease Innovation,..."},{"title":"Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Customer/Partner Customer Service Satisfaction Surveys","type":"Notice","abstract":"The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.","document_number":"2026-18691","html_url":"https://www.federalregister.gov/documents/2026/09/14/2026-18691/agency-information-collection-activities-submission-for-office-of-management-and-budget-review","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-09-14/pdf/2026-18691.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-18691.pdf?1789130717","publication_date":"2026-09-14","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995."},{"title":"Medical Devices; Cardiovascular Devices; Classification of the Cardiovascular Machine Learning-Based Notification Software","type":"Rule","abstract":"The Food and Drug Administration (FDA) is classifying the cardiovascular machine learning-based notification software 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 cardiovascular machine learning- based notification software. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the 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.","document_number":"2026-18612","html_url":"https://www.federalregister.gov/documents/2026/09/11/2026-18612/medical-devices-cardiovascular-devices-classification-of-the-cardiovascular-machine-learning-based","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-09-11/pdf/2026-18612.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-18612.pdf?1789044319","publication_date":"2026-09-11","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"The Food and Drug Administration (FDA) is classifying the cardiovascular machine learning-based notification software into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of..."},{"title":"Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use, and Related Information; Aminobenzoic Acid (PABA) and Trolamine Salicylate","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability on its website of the final administrative order (final order) (OTC000008-1) titled \"Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use, and Related Information; Aminobenzoic Acid (PABA) and Trolamine Salicylate.\" This final order amends \"Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use\" (Over- the-Counter (OTC) Monograph M020) to remove PABA and trolamine salicylate as sunscreen active ingredients. A sunscreen drug product containing PABA or trolamine salicylate is not generally recognized as safe and effective (GRASE).","document_number":"2026-18551","html_url":"https://www.federalregister.gov/documents/2026/09/11/2026-18551/amending-over-the-counter-monograph-m020-sunscreen-drug-products-for-over-the-counter-human-use-and","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-09-11/pdf/2026-18551.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-18551.pdf?1789044312","publication_date":"2026-09-11","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"The Food and Drug Administration (FDA or Agency) is announcing the availability on its website of the final administrative order (final order) (OTC000008-1) titled \"Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter..."},{"title":"Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Tracking","type":"Notice","abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection requirements for the tracking of medical devices.","document_number":"2026-18529","html_url":"https://www.federalregister.gov/documents/2026/09/11/2026-18529/agency-information-collection-activities-proposed-collection-comment-request-medical-device-tracking","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-09-11/pdf/2026-18529.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-18529.pdf?1789044309","publication_date":"2026-09-11","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to..."},{"title":"Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for Qualitative Data To Support Social and Behavioral Research for Food, Dietary Supplements, Cosmetics, and Animal Food and Feed","type":"Notice","abstract":"The Food and Drug Administration (FDA or the Agency) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.","document_number":"2026-18528","html_url":"https://www.federalregister.gov/documents/2026/09/11/2026-18528/agency-information-collection-activities-submission-for-office-of-management-and-budget-review","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-09-11/pdf/2026-18528.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-18528.pdf?1789044309","publication_date":"2026-09-11","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"The Food and Drug Administration (FDA or the Agency) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995."},{"title":"Green Innovation GmbH; Withdrawal of Food Additive Petition (Animal Use)","type":"Proposed Rule","abstract":"The Food and Drug Administration (FDA or we) is announcing the withdrawal, without prejudice to a future filing, of a food additive petition (FAP 2323) proposing that the food additive regulations be amended to provide for the safe use of hydrolyzed lignin as a source of neutral detergent soluble fiber in food for broiler chickens, laying hens, turkeys, growing swine, sows, lactating dairy cows, beef cattle, sheep, goats, salmonids, and adult dogs at no more than 1% of the food on a weight basis or 10 kilograms per metric ton of food.","document_number":"2026-18469","html_url":"https://www.federalregister.gov/documents/2026/09/10/2026-18469/green-innovation-gmbh-withdrawal-of-food-additive-petition-animal-use","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-09-10/pdf/2026-18469.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-18469.pdf?1788957916","publication_date":"2026-09-10","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"The Food and Drug Administration (FDA or we) is announcing the withdrawal, without prejudice to a future filing, of a food additive petition (FAP 2323) proposing that the food additive regulations be amended to provide for the safe use of hydrolyzed..."},{"title":"Fee Rate for Using a Priority Review Voucher in Fiscal Year 2027","type":"Notice","abstract":"The Food and Drug Administration (FDA or the Agency) is announcing the fee rate for using a priority review voucher for fiscal year (FY) 2027. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended, authorizes FDA to determine and collect priority review user fees for certain applications for review of human drug or biological products when those applications use a tropical disease, rare pediatric disease, or material threat medical countermeasure (MCM) priority review voucher. These vouchers are awarded to the sponsors of tropical disease, rare pediatric disease, or material threat MCM product applications, respectively, that meet the requirements of the FD&C Act, upon FDA approval of such applications. The amount of the fee for using a priority review voucher is determined each fiscal year, based on the difference between the average cost incurred by FDA to review a human drug application designated as priority review in the previous fiscal year, and the average cost incurred in the review of an application that is not subject to priority review in the previous fiscal year. This notice establishes the FY 2027 priority review fee rate applicable to submission of eligible applications for review of human drug or biological products using a tropical disease, rare pediatric disease, or material threat MCM priority review voucher and outlines the payment procedures for such fees.","document_number":"2026-18464","html_url":"https://www.federalregister.gov/documents/2026/09/10/2026-18464/fee-rate-for-using-a-priority-review-voucher-in-fiscal-year-2027","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-09-10/pdf/2026-18464.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-18464.pdf?1788957915","publication_date":"2026-09-10","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"The Food and Drug Administration (FDA or the Agency) is announcing the fee rate for using a priority review voucher for fiscal year (FY) 2027. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended, authorizes FDA to determine and collect..."},{"title":"Medical Devices; Cardiovascular Devices; Classification of the Mechanical Deviation Device for Esophageal Protection During Cardiac Ablation Procedures","type":"Rule","abstract":"The Food and Drug Administration (FDA) is classifying the mechanical deviation device for esophageal protection during cardiac ablation procedures 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 mechanical deviation device for esophageal protection during cardiac ablation procedures. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the 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.","document_number":"2026-18433","html_url":"https://www.federalregister.gov/documents/2026/09/10/2026-18433/medical-devices-cardiovascular-devices-classification-of-the-mechanical-deviation-device-for","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-09-10/pdf/2026-18433.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-18433.pdf?1788957912","publication_date":"2026-09-10","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"The Food and Drug Administration (FDA) is classifying the mechanical deviation device for esophageal protection during cardiac ablation procedures into class II (special controls). The special controls that apply to the device type are identified in..."},{"title":"Medical Devices; Cardiovascular Devices; Classification of the Temperature Regulation Device for Esophageal Protection During Cardiac Ablation Procedures","type":"Rule","abstract":"The Food and Drug Administration (FDA) is classifying the temperature regulation device for esophageal protection during cardiac ablation procedures 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 temperature regulation device for esophageal protection during cardiac ablation procedures. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the 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.","document_number":"2026-18432","html_url":"https://www.federalregister.gov/documents/2026/09/10/2026-18432/medical-devices-cardiovascular-devices-classification-of-the-temperature-regulation-device-for","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-09-10/pdf/2026-18432.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-18432.pdf?1788957911","publication_date":"2026-09-10","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"The Food and Drug Administration (FDA) is classifying the temperature regulation device for esophageal protection during cardiac ablation procedures into class II (special controls). The special controls that apply to the device type are identified in..."},{"title":"Medical Devices; Cardiovascular Devices; Classification of the Extravascular Support for an Arteriovenous Fistula for Vascular Access","type":"Rule","abstract":"The Food and Drug Administration (FDA) is classifying the extravascular support for an arteriovenous fistula for vascular access 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 extravascular support for an arteriovenous fistula for vascular access. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the 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.","document_number":"2026-18431","html_url":"https://www.federalregister.gov/documents/2026/09/10/2026-18431/medical-devices-cardiovascular-devices-classification-of-the-extravascular-support-for-an","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-09-10/pdf/2026-18431.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-18431.pdf?1788957911","publication_date":"2026-09-10","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"The Food and Drug Administration (FDA) is classifying the extravascular support for an arteriovenous fistula for vascular access into class II (special controls). The special controls that apply to the device type are identified in this order and will..."},{"title":"Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Anti-Tumor Necrosis Factor Alpha Monoclonal Antibody Test System for Inflammatory Bowel Disease","type":"Rule","abstract":"The Food and Drug Administration (FDA) is classifying the anti-tumor necrosis factor alpha monoclonal antibody test system for inflammatory bowel disease 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 anti-tumor necrosis factor alpha monoclonal antibody test system for inflammatory bowel disease. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the 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.","document_number":"2026-18430","html_url":"https://www.federalregister.gov/documents/2026/09/10/2026-18430/medical-devices-clinical-chemistry-and-clinical-toxicology-devices-classification-of-the-anti-tumor","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-09-10/pdf/2026-18430.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-18430.pdf?1788957911","publication_date":"2026-09-10","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"The Food and Drug Administration (FDA) is classifying the anti-tumor necrosis factor alpha monoclonal antibody test system for inflammatory bowel disease into class II (special controls). The special controls that apply to the device type are..."},{"title":"Medical Devices; Ear, Nose, and Throat Devices; Classification of the Cooperative Powered Surgical Assist Device for ENT Surgery","type":"Rule","abstract":"The Food and Drug Administration (FDA) is classifying the cooperative powered surgical assist device for ear, nose, and throat (ENT) surgery 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 cooperative powered surgical assist device for ENT surgery. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the 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.","document_number":"2026-18429","html_url":"https://www.federalregister.gov/documents/2026/09/10/2026-18429/medical-devices-ear-nose-and-throat-devices-classification-of-the-cooperative-powered-surgical","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-09-10/pdf/2026-18429.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-18429.pdf?1788957911","publication_date":"2026-09-10","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"The Food and Drug Administration (FDA) is classifying the cooperative powered surgical assist device for ear, nose, and throat (ENT) surgery into class II (special controls). The special controls that apply to the device type are identified in this..."}]}