# Food and Drug Administration 82 documents across 22 days of the archive, 12 of them final rules. The five most recent days are below. [HTML](https://downstream.sh/daily/agency/food-and-drug-administration/) · [the long-form archive](https://downstream.sh/daily/agency/food-and-drug-administration/archive.md) · [the daily issue](https://downstream.sh/daily/index.md) ## Dates this agency has set that have not yet arrived | Date | Offset | What | Document | Agency | |---|---|---|---|---| | 2026-09-11 | today | Takes effect | [Medical Devices; Cardiovascular Devices; Classification of the Cardiovascular Machine Learning-Based Notification Software](https://www.federalregister.gov/documents/2026/09/11/2026-18612/medical-devices-cardiovascular-devices-classification-of-the-cardiovascular-machine-learning-based) | Health and Human Services Department · Food and Drug Administration | | 2026-09-16 | +5d | Takes effect | [Hematology and Pathology Devices; Reclassification of In Situ Hybridization Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product](https://www.federalregister.gov/documents/2026/08/17/2026-16727/hematology-and-pathology-devices-reclassification-of-in-situ-hybridization-test-systems-for-use-with) | Health and Human Services Department · Food and Drug Administration | | 2026-09-16 | +5d | Comments close | [Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational New Drug Application Requirements](https://www.federalregister.gov/documents/2026/08/17/2026-16715/agency-information-collection-activities-proposed-collection-comment-request-investigational-new) | Health and Human Services Department · Food and Drug Administration | | 2026-09-18 | +7d | Comments close | [International Association of Color Manufacturers; Filing of Color Additive Petition](https://www.federalregister.gov/documents/2026/08/19/2026-16943/international-association-of-color-manufacturers-filing-of-color-additive-petition) | Health and Human Services Department · Food and Drug Administration | | 2026-09-18 | +7d | Comments close | [Food Additives Permitted in Feed and Drinking Water of Animals; Chromium DL-methionine Chelate](https://www.federalregister.gov/documents/2026/08/19/2026-16942/food-additives-permitted-in-feed-and-drinking-water-of-animals-chromium-dl-methionine-chelate) | Health and Human Services Department · Food and Drug Administration | | 2026-09-28 | +17d | Comments close | [Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Importation of Prescription Drugs](https://www.federalregister.gov/documents/2026/08/28/2026-17603/agency-information-collection-activities-submission-for-office-of-management-and-budget-review) | Health and Human Services Department · Food and Drug Administration | | 2026-09-28 | +17d | Comments close | [Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reporting Associated With Animal Drug and Animal Generic Drug User Fees](https://www.federalregister.gov/documents/2026/08/28/2026-17601/agency-information-collection-activities-submission-for-office-of-management-and-budget-review) | Health and Human Services Department · Food and Drug Administration | | 2026-09-30 | +19d | Comments close | [Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Potential Tobacco Product Violations Reporting Form](https://www.federalregister.gov/documents/2026/08/31/2026-17677/agency-information-collection-activities-submission-for-office-of-management-and-budget-review) | Health and Human Services Department · Food and Drug Administration | | 2026-10-01 | +20d | Takes effect | [Fee Rate for Using a Priority Review Voucher in Fiscal Year 2027](https://www.federalregister.gov/documents/2026/09/10/2026-18464/fee-rate-for-using-a-priority-review-voucher-in-fiscal-year-2027) | Health and Human Services Department · Food and Drug Administration | | 2026-10-09 | +28d | Comments close | [Radiology Devices; Reclassification of Digital Breast Tomosynthesis System](https://www.federalregister.gov/documents/2026/08/10/2026-16209/radiology-devices-reclassification-of-digital-breast-tomosynthesis-system) | Health and Human Services Department · Food and Drug Administration | | 2026-10-13 | +32d | Comments close | [Container Closure Systems for Human Drugs and Biological Products; Draft Guidance for Industry; Availability](https://www.federalregister.gov/documents/2026/08/14/2026-16638/container-closure-systems-for-human-drugs-and-biological-products-draft-guidance-for-industry) | Health and Human Services Department · Food and Drug Administration | | 2026-10-13 | +32d | Comments close | [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](https://www.federalregister.gov/documents/2026/09/11/2026-18528/agency-information-collection-activities-submission-for-office-of-management-and-budget-review) | Health and Human Services Department · Food and Drug Administration | | 2026-10-16 | +35d | Comments close | [Medical Devices; Classification of Accessories Distinct From Other Devices; Proposed List of Accessories Suitable for Class I; Request for Comments](https://www.federalregister.gov/documents/2026/08/17/2026-16729/medical-devices-classification-of-accessories-distinct-from-other-devices-proposed-list-of) | Health and Human Services Department · Food and Drug Administration | | 2026-10-16 | +35d | Comments close | [Gastroenterology-Urology Devices; Reclassification of Diagnostic Endoscopic Light Source Systems To Be Renamed Cystoscopic Systems Intended as an Aid for Detection of Bladder Cancer](https://www.federalregister.gov/documents/2026/08/17/2026-16728/gastroenterology-urology-devices-reclassification-of-diagnostic-endoscopic-light-source-systems-to) | Health and Human Services Department · Food and Drug Administration | | 2026-10-16 | +35d | Comments close | [Agency Information Collection Activities; Proposed Collection; Comment Request; Third Party Disclosure and Recordkeeping Requirements for Reportable Food](https://www.federalregister.gov/documents/2026/08/17/2026-16714/agency-information-collection-activities-proposed-collection-comment-request-third-party-disclosure) | Health and Human Services Department · Food and Drug Administration | | 2026-10-16 | +35d | Comments close | [Determination of Regulatory Review Period for Purposes of Patent Extension; BIZENGRI](https://www.federalregister.gov/documents/2026/08/17/2026-16713/determination-of-regulatory-review-period-for-purposes-of-patent-extension-bizengri) | Health and Human Services Department · Food and Drug Administration | | 2026-10-16 | +35d | Comments close | [Agency Information Collection Activities; Proposed Collection; Comment Request; Imports and Electronic Import Entries](https://www.federalregister.gov/documents/2026/08/17/2026-16712/agency-information-collection-activities-proposed-collection-comment-request-imports-and-electronic) | Health and Human Services Department · Food and Drug Administration | | 2026-10-17 | +36d | Comments close | [Reauthorization of the Generic Drug User Fee Amendments; Public Meeting; Request for Comments](https://www.federalregister.gov/documents/2026/08/11/2026-16353/reauthorization-of-the-generic-drug-user-fee-amendments-public-meeting-request-for-comments) | Health and Human Services Department · Food and Drug Administration | | 2026-10-19 | +38d | Comments close | [Determining Whether To Submit an ANDA or a 505(b)(2) Application; Draft Guidance for Industry; Availability](https://www.federalregister.gov/documents/2026/08/18/2026-16837/determining-whether-to-submit-an-anda-or-a-505b2-application-draft-guidance-for-industry) | Health and Human Services Department · Food and Drug Administration | | 2026-10-23 | +42d | Comments close | [Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability](https://www.federalregister.gov/documents/2026/08/24/2026-17222/product-specific-guidances-draft-and-revised-draft-guidances-for-industry-availability) | Health and Human Services Department · Food and Drug Administration | | 2026-10-26 | +45d | Comments close | [Agency Information Collection Activities; Proposed Collection; Comment Request; Allegations of Regulatory Misconduct Voluntarily Submitted to the Center for Devices and Radiological Health](https://www.federalregister.gov/documents/2026/08/26/2026-17377/agency-information-collection-activities-proposed-collection-comment-request-allegations-of) | Health and Human Services Department · Food and Drug Administration | | 2026-10-27 | +46d | Comments close | [Agency Information Collection Activities; Proposed Collection; Comment Request; Qualitative Feedback on Agency Service Delivery](https://www.federalregister.gov/documents/2026/08/28/2026-17605/agency-information-collection-activities-proposed-collection-comment-request-qualitative-feedback-on) | Health and Human Services Department · Food and Drug Administration | | 2026-10-27 | +46d | Comments close | [Agency Information Collection Activities; Proposed Collection; Comment Request; Food Canning Establishment Registration, Process Filing, and Recordkeeping for Acidified Foods and Thermally Processed Low-Acid Foods in Hermetically Sealed Containers](https://www.federalregister.gov/documents/2026/08/28/2026-17599/agency-information-collection-activities-proposed-collection-comment-request-food-canning) | Health and Human Services Department · Food and Drug Administration | | 2026-10-27 | +46d | Comments close | [Agency Information Collection Activities; Proposed Collection; Comment Request; Focus Groups and Interviews as Used by the Food and Drug Administration](https://www.federalregister.gov/documents/2026/08/28/2026-17598/agency-information-collection-activities-proposed-collection-comment-request-focus-groups-and) | Health and Human Services Department · Food and Drug Administration | | 2026-10-30 | +49d | Comments close | [Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic Act and Associated Fees](https://www.federalregister.gov/documents/2026/08/31/2026-17676/agency-information-collection-activities-proposed-collection-comment-request-registration-of-human) | Health and Human Services Department · Food and Drug Administration | | 2026-10-30 | +49d | Comments close | [Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Reports of Removals and Corrections](https://www.federalregister.gov/documents/2026/08/31/2026-17675/agency-information-collection-activities-proposed-collection-comment-request-medical-devices-reports) | Health and Human Services Department · Food and Drug Administration | | 2026-11-03 | +53d | Comments close | [Advancing Development of Botanical Drug Products; Request for Information](https://www.federalregister.gov/documents/2026/09/04/2026-18133/advancing-development-of-botanical-drug-products-request-for-information) | Health and Human Services Department · Food and Drug Administration | | 2026-11-09 | +59d | Comments close | [Agency Information Collection Activities; Proposed Collection; Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based Products](https://www.federalregister.gov/documents/2026/09/09/2026-18333/agency-information-collection-activities-proposed-collection-comment-request-human-cells-tissues-and) | Health and Human Services Department · Food and Drug Administration | | 2026-11-09 | +59d | Comments close | [Agency Information Collection Activities; Proposed Collection; Comment Request; Pregnancy Exposure Registry Enrollment Project: A Survey of Health Care Providers To Advance Pregnancy Safety Data Collection and Improve Health Communications](https://www.federalregister.gov/documents/2026/09/09/2026-18299/agency-information-collection-activities-proposed-collection-comment-request-pregnancy-exposure) | Health and Human Services Department · Food and Drug Administration | | 2026-11-10 | +60d | Comments close | [Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Tracking](https://www.federalregister.gov/documents/2026/09/11/2026-18529/agency-information-collection-activities-proposed-collection-comment-request-medical-device-tracking) | Health and Human Services Department · Food and Drug Administration | ## 11 September 2026 — 4 documents [the whole issue for this day](https://downstream.sh/daily/2026-09-11.md) > The FDA classified cardiovascular machine learning-based notification software as class II medical devices and amended sunscreen monograph requirements. — via Downstream, https://downstream.sh/daily/agency/food-and-drug-administration/#s-2026-09-11 *Machine-written by `claude-haiku-4-5-20251001` from the documents below.* ### Medical Devices; Cardiovascular Devices; Classification of the Cardiovascular Machine Learning-Based Notification Software *Rule* — Health and Human Services Department · Food and Drug Administration 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. - **Takes effect** 11 September 2026 (today) 91 FR 57785 · FR Doc. 2026-18612 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-11/pdf/2026-18612.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/11/2026-18612/medical-devices-cardiovascular-devices-classification-of-the-cardiovascular-machine-learning-based) ### Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use, and Related Information; Aminobenzoic Acid (PABA) and Trolamine Salicylate *Notice* — Health and Human Services Department · Food and Drug Administration 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). 91 FR 57892 · FR Doc. 2026-18551 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-11/pdf/2026-18551.pdf) · [federalregister.gov](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) ### Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Tracking *Notice* — Health and Human Services Department · Food and Drug Administration 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. - **Comments close** 10 November 2026 (in 60 days) 91 FR 57893 · FR Doc. 2026-18529 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-11/pdf/2026-18529.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/11/2026-18529/agency-information-collection-activities-proposed-collection-comment-request-medical-device-tracking) ### 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 *Notice* — Health and Human Services Department · Food and Drug Administration 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. - **Comments close** 13 October 2026 (in 32 days) 91 FR 57895 · FR Doc. 2026-18528 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-11/pdf/2026-18528.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/11/2026-18528/agency-information-collection-activities-submission-for-office-of-management-and-budget-review) ## 10 September 2026 — 10 documents [the whole issue for this day](https://downstream.sh/daily/2026-09-10.md) > The FDA published ten documents including one proposed rule withdrawing a food additive petition, one notice establishing a fiscal year 2027 priority review voucher fee rate, and eight rules classifying medical devices. — via Downstream, https://downstream.sh/daily/agency/food-and-drug-administration/#s-2026-09-10 *Machine-written by `claude-haiku-4-5-20251001` from the documents below.* ### Green Innovation GmbH; Withdrawal of Food Additive Petition (Animal Use) *Proposed Rule* — Health and Human Services Department · Food and Drug Administration 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. 91 FR 57531 · FR Doc. 2026-18469 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-10/pdf/2026-18469.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/10/2026-18469/green-innovation-gmbh-withdrawal-of-food-additive-petition-animal-use) ### Fee Rate for Using a Priority Review Voucher in Fiscal Year 2027 *Notice* — Health and Human Services Department · Food and Drug Administration 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. - **Takes effect** 1 October 2026 (in 20 days) 91 FR 57617 · FR Doc. 2026-18464 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-10/pdf/2026-18464.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/10/2026-18464/fee-rate-for-using-a-priority-review-voucher-in-fiscal-year-2027) ### Medical Devices; Cardiovascular Devices; Classification of the Mechanical Deviation Device for Esophageal Protection During Cardiac Ablation Procedures *Rule* — Health and Human Services Department · Food and Drug Administration 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. - **Takes effect** 10 September 2026 (1 days ago) 91 FR 57495 · FR Doc. 2026-18433 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-10/pdf/2026-18433.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/10/2026-18433/medical-devices-cardiovascular-devices-classification-of-the-mechanical-deviation-device-for) ### Medical Devices; Cardiovascular Devices; Classification of the Temperature Regulation Device for Esophageal Protection During Cardiac Ablation Procedures *Rule* — Health and Human Services Department · Food and Drug Administration 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. - **Takes effect** 10 September 2026 (1 days ago) 91 FR 57500 · FR Doc. 2026-18432 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-10/pdf/2026-18432.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/10/2026-18432/medical-devices-cardiovascular-devices-classification-of-the-temperature-regulation-device-for) ### Medical Devices; Cardiovascular Devices; Classification of the Extravascular Support for an Arteriovenous Fistula for Vascular Access *Rule* — Health and Human Services Department · Food and Drug Administration 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. - **Takes effect** 10 September 2026 (1 days ago) 91 FR 57498 · FR Doc. 2026-18431 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-10/pdf/2026-18431.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/10/2026-18431/medical-devices-cardiovascular-devices-classification-of-the-extravascular-support-for-an) ### Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Anti-Tumor Necrosis Factor Alpha Monoclonal Antibody Test System for Inflammatory Bowel Disease *Rule* — Health and Human Services Department · Food and Drug Administration 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. - **Takes effect** 10 September 2026 (1 days ago) 91 FR 57493 · FR Doc. 2026-18430 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-10/pdf/2026-18430.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/10/2026-18430/medical-devices-clinical-chemistry-and-clinical-toxicology-devices-classification-of-the-anti-tumor) ### Medical Devices; Ear, Nose, and Throat Devices; Classification of the Cooperative Powered Surgical Assist Device for ENT Surgery *Rule* — Health and Human Services Department · Food and Drug Administration 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. - **Takes effect** 10 September 2026 (1 days ago) 91 FR 57502 · FR Doc. 2026-18429 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-10/pdf/2026-18429.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/10/2026-18429/medical-devices-ear-nose-and-throat-devices-classification-of-the-cooperative-powered-surgical) ### Medical Devices; Gastroenterology-Urology Devices; Classification of the Implanted Tibial Electrical Urinary Continence Device *Rule* — Health and Human Services Department · Food and Drug Administration The Food and Drug Administration (FDA) is classifying the implanted tibial electrical urinary continence 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 implanted tibial electrical urinary continence device. 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. - **Takes effect** 10 September 2026 (1 days ago) 91 FR 57504 · FR Doc. 2026-18428 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-10/pdf/2026-18428.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/10/2026-18428/medical-devices-gastroenterology-urology-devices-classification-of-the-implanted-tibial-electrical) ### Medical Devices; Radiology Devices; Classification of the Vaginal Hydrogel Packing System *Rule* — Health and Human Services Department · Food and Drug Administration The Food and Drug Administration (FDA) is classifying the vaginal hydrogel packing 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 vaginal hydrogel packing system. 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. - **Takes effect** 10 September 2026 (1 days ago) 91 FR 57509 · FR Doc. 2026-18427 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-10/pdf/2026-18427.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/10/2026-18427/medical-devices-radiology-devices-classification-of-the-vaginal-hydrogel-packing-system) ### Medical Devices; General Hospital and Personal Use Devices; Classification of the Whole Room Microbial Reduction Device *Rule* — Health and Human Services Department · Food and Drug Administration The Food and Drug Administration (FDA) is classifying the whole room microbial reduction 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 whole room microbial reduction device. 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. - **Takes effect** 10 September 2026 (1 days ago) 91 FR 57507 · FR Doc. 2026-18426 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-10/pdf/2026-18426.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/10/2026-18426/medical-devices-general-hospital-and-personal-use-devices-classification-of-the-whole-room-microbial) ## 9 September 2026 — 7 documents [the whole issue for this day](https://downstream.sh/daily/2026-09-09.md) > The Food and Drug Administration published seven notices on September 9, 2026, including guidance on neonatal parenteral nutrition compounding and patent extension determinations. — via Downstream, https://downstream.sh/daily/agency/food-and-drug-administration/#s-2026-09-09 *Machine-written by `claude-haiku-4-5-20251001` from the documents below.* ### Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates; Guidance for Industry; Availability *Notice* — Health and Human Services Department · Food and Drug Administration The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a guidance for industry titled "Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates." This guidance describes the FDA's regulatory and enforcement priorities regarding the compounding of certain starter parenteral nutrition drug products for neonates by outsourcing facilities and by State-licensed pharmacies and Federal facilities that are not registered with FDA as outsourcing facilities. This guidance is being published for immediate implementation due to the expected market exit of the predominant source of certain starter parenteral nutrition drug products for neonates in the United States. 91 FR 57358 · FR Doc. 2026-18368 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-09/pdf/2026-18368.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/09/2026-18368/temporary-policies-for-compounding-certain-starter-parenteral-nutrition-drug-products-for-neonates) ### Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-2027 Southern Hemisphere Influenza Virus Vaccines *Notice* — Health and Human Services Department · Food and Drug Administration The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document. 91 FR 57359 · FR Doc. 2026-18349 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-09/pdf/2026-18349.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/09/2026-18349/vaccines-and-related-biological-products-advisory-committee-notice-of-meeting-establishment-of-a) ### Agency Information Collection Activities; Proposed Collection; Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based Products *Notice* — Health and Human Services Department · Food and Drug Administration The Food and Drug Administration (FDA or Agency) 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 reinstatement of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection associated with statutory and regulatory requirements that govern certain human cells, tissues, and cellular and tissue-based products (HCT/Ps). - **Comments close** 9 November 2026 (in 59 days) 91 FR 57347 · FR Doc. 2026-18333 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-09/pdf/2026-18333.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/09/2026-18333/agency-information-collection-activities-proposed-collection-comment-request-human-cells-tissues-and) ### Determination of Regulatory Review Period for Purposes of Patent Extension; ANDEMBRY *Notice* — Health and Human Services Department · Food and Drug Administration The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ANDEMBRY and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of patents which claim that human biological product. - **Comments close** 8 March 2027 (in 178 days) 91 FR 57356 · FR Doc. 2026-18300 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-09/pdf/2026-18300.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/09/2026-18300/determination-of-regulatory-review-period-for-purposes-of-patent-extension-andembry) ### Agency Information Collection Activities; Proposed Collection; Comment Request; Pregnancy Exposure Registry Enrollment Project: A Survey of Health Care Providers To Advance Pregnancy Safety Data Collection and Improve Health Communications *Notice* — Health and Human Services Department · Food and Drug Administration The Food and Drug Administration (FDA or Agency) 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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on a proposed study entitled "Pregnancy Exposure Registry Enrollment Project: A Survey of Health Care Providers to Advance Pregnancy Safety Data Collection and Improve Health Communications." - **Comments close** 9 November 2026 (in 59 days) 91 FR 57352 · FR Doc. 2026-18299 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-09/pdf/2026-18299.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/09/2026-18299/agency-information-collection-activities-proposed-collection-comment-request-pregnancy-exposure) ### Determination of Regulatory Review Period for Purposes of Patent Extension; ANZUPGO *Notice* — Health and Human Services Department · Food and Drug Administration The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ANZUPGO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product. - **Comments close** 8 March 2027 (in 178 days) 91 FR 57355 · FR Doc. 2026-18298 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-09/pdf/2026-18298.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/09/2026-18298/determination-of-regulatory-review-period-for-purposes-of-patent-extension-anzupgo) ### Determination of Regulatory Review Period for Purposes of Patent Extension; ANKTIVA *Notice* — Health and Human Services Department · Food and Drug Administration The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ANKTIVA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of patents which claim that human biological product. - **Comments close** 8 March 2027 (in 178 days) 91 FR 57350 · FR Doc. 2026-18297 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-09/pdf/2026-18297.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/09/2026-18297/determination-of-regulatory-review-period-for-purposes-of-patent-extension-anktiva) ## 4 September 2026 — 1 document [the whole issue for this day](https://downstream.sh/daily/2026-09-04.md) > The FDA published a notice requesting information on advancing botanical drug product development, with comments due November 3, 2026. — via Downstream, https://downstream.sh/daily/agency/food-and-drug-administration/#s-2026-09-04 *Machine-written by `claude-haiku-4-5-20251001` from the documents below.* ### Advancing Development of Botanical Drug Products; Request for Information *Notice* — Health and Human Services Department · Food and Drug Administration The Food and Drug Administration (FDA or Agency) is opening a public docket to solicit comments on FDA's efforts to advance development of botanical drug products (BDPs). FDA is publishing this request for information to better understand stakeholders' perspectives on the state of BDP development in the United States, challenges encountered, and potential solutions to gathering the information required by the Federal Food, Drug, and Cosmetic Act (FD&C Act). - **Comments close** 3 November 2026 (in 53 days) 91 FR 56887 · FR Doc. 2026-18133 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-04/pdf/2026-18133.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/04/2026-18133/advancing-development-of-botanical-drug-products-request-for-information) ## 3 September 2026 — 1 document [the whole issue for this day](https://downstream.sh/daily/2026-09-03.md) > The FDA determined that Phenaphen with Codeine No. 3 and No. 4 oral capsules were not withdrawn for safety or effectiveness reasons. — via Downstream, https://downstream.sh/daily/agency/food-and-drug-administration/#s-2026-09-03 *Machine-written by `claude-haiku-4-5-20251001` from the documents below.* ### Determination That PHENAPHEN WITH CODEINE NO. 3 (Acetaminophen; Codeine Phosphate) Oral Capsules, 325 Milligrams and 30 Milligrams, and PHENAPHEN WITH CODEINE NO. 4 (Acetaminophen; Codeine Phosphate) Oral Capsules, 325 Milligrams and 60 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness *Notice* — Health and Human Services Department · Food and Drug Administration The Food and Drug Administration (FDA or Agency) has determined that PHENAPHEN WITH CODEINE NO. 3 (acetaminophen; codeine phosphate) oral capsules, 325 milligrams (mg) and 30 mg, and PHENAPHEN WITH CODEINE NO. 4 (acetaminophen; codeine phosphate) oral capsules, 325 mg and 60 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for PHENAPHEN WITH CODEINE NO. 3 (acetaminophen; codeine phosphate) oral capsules, 325 mg and 30 mg, and PHENAPHEN WITH CODEINE NO. 4 (acetaminophen; codeine phosphate) oral capsules, 325 mg and 60 mg, if all other legal and regulatory requirements are met. 91 FR 56654 · FR Doc. 2026-18023 · [official PDF](https://www.govinfo.gov/content/pkg/FR-2026-09-03/pdf/2026-18023.pdf) · [federalregister.gov](https://www.federalregister.gov/documents/2026/09/03/2026-18023/determination-that-phenaphen-with-codeine-no-3-acetaminophen-codeine-phosphate-oral-capsules-325) ## Earlier 17 further days are in the [long-form archive](https://downstream.sh/daily/agency/food-and-drug-administration/archive.md). ## Ask an assistant instead Everything on this page is also a tool call. Add `mcp.downstream.sh` as an MCP server — no key, no account — then paste this: ``` Using the Downstream MCP server at mcp.downstream.sh, call whats_new_since with agency "Food and Drug Administration" since 2026-09-03, then summarise what changed and list every deadline it created. ``` Reaches `whats_new_since`. The response carries its own citations and states what it is missing, including which dates it has no record for. --- Every document linked here is a work of the United States government and in the public domain. The Federal Register's HTML and XML renderings are unofficial; the PDF on each item is the official text, and that is the one to cite. Counts are arithmetic over published fields, dates are printed as filed, and titles are verbatim. Where we have nothing, this says nothing rather than estimating. The one-sentence agency summaries are machine-written from those same fields and are labelled where they appear. 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