Health and Human Services Department

§ 03 Recent material actions

• M5 Jun 2, 2026 Health and Human Services Department

  Notice of Vacatur Regarding Certain Provisions of the 2024 Nondiscrimination in Health Programs and Activities Final Rule

  HHS gives notice that a federal district court vacated portions of the 2024 Section 1557 nondiscrimination final rule that treated sex discrimination under Title IX as including gender-identity discrimination. Those vacated provisions are legally void, while the remainder of the 2024 Section 1557 rule remains in effect.

• M4 Jun 1, 2026 Health and Human Services Department

  Medical Devices; General Hospital and Personal Use Devices; Classification of the Rigid Sterilization Container With Electronic Monitoring

  Action: Verify affected devices meet the new class II special controls by 2026-06-01.

  FDA classifies rigid sterilization containers with electronic monitoring as class II medical devices subject to special controls. The rule codifies device-specific controls intended to provide reasonable assurance of safety and effectiveness and establishes the regulatory pathway for this device type.

• M3 Jun 1, 2026 Health and Human Services Department

  Medical Devices; Anesthesiology Devices; Classification of the Real-Time Ultrasound Anatomy Visualization and Labeling Device for Ultrasound Guided Regional Anesthesia

  Action: Assess whether covered devices meet the new FDA class II special controls.

  FDA classifies real-time ultrasound anatomy visualization and labeling devices used for ultrasound-guided regional anesthesia as class II medical devices subject to special controls. The rule establishes the device type in the anesthesiology devices classification regulations, enabling regulation through class II controls rather than default higher-burden pathways.

• M4 Jun 1, 2026 Health and Human Services Department

  Medical Devices; Anesthesiology Devices; Classification of the Adjunctive Pain Measurement Device for Anesthesiology

  Action: Ensure adjunctive pain measurement devices meet FDA class II special controls as of 2026-06-01.

  FDA classifies adjunctive pain measurement devices for anesthesiology as class II medical devices subject to special controls. The rule codifies the device type and applicable controls, moving it into a regulated pathway intended to provide reasonable assurance of safety and effectiveness while facilitating market access.

• M4 Jun 1, 2026 Health and Human Services Department

  Medical Devices; Gastroenterology-Urology Devices; Classification of the Orally Ingested Transient Device for Constipation

  Action: Ensure orally ingested transient constipation devices meet class II special controls as of 2026-06-01.

  FDA classifies orally ingested transient devices for constipation as class II gastroenterology-urology devices subject to special controls. The rule codifies the device type and applicable controls, creating a 510(k)-type regulatory pathway rather than requiring the highest-risk classification.

• M4 Jun 1, 2026 Health and Human Services Department

  Medical Devices; Dental Devices; Classification of the Intraoral Cooling Device

  Action: Review intraoral cooling device submissions and labeling for compliance with FDA class II special controls.

  FDA classifies intraoral cooling devices as class II dental devices subject to special controls. The rule creates a codified regulatory classification for this device type, establishing the controls manufacturers must satisfy to provide reasonable assurance of safety and effectiveness.

• M4 Jun 1, 2026 Health and Human Services Department

  Medical Devices; Hematology and Pathology Devices; Classification of the Von Willebrand Factor Assay

  Action: Ensure von Willebrand factor assays meet class II special controls as of 2026-06-01.

  FDA classifies the von Willebrand factor assay as a class II medical device subject to special controls. The rule codifies device-specific requirements intended to provide reasonable assurance of safety and effectiveness and creates a regulated pathway for marketing these assays under class II controls.

• M4 Jun 1, 2026 Health and Human Services Department

  Medical Devices; Ear, Nose, and Throat Devices; Classification of the Oropharyngeal Electrical Stimulator

  Action: Review class II special controls before marketing oropharyngeal electrical stimulators.

  FDA classifies oropharyngeal electrical stimulators used in ear, nose, and throat applications as class II medical devices subject to special controls. The rule codifies the device type and applicable controls, creating a defined regulatory pathway for future marketing of these devices.

• M4 Jun 1, 2026 Health and Human Services Department

  Medicare Program; Alternative Payment Model Updates and the Increasing Organ Transplant Access (IOTA) Model

  CMS finalizes updates to the Increasing Organ Transplant Access Model for Performance Year 2, revising how participating Medicare kidney transplant hospitals are measured and paid under the model. The rule also makes a technical correction to the regulatory text.

• M3 Jun 1, 2026 Health and Human Services Department

  Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Draft Guidance for Industry; Availability

  FDA announces the availability of a draft guidance describing streamlined approaches to general toxicology and other nonclinical safety assessments for certain oncology biologics and conjugated products. The draft is intended to reduce unnecessary animal studies, including non-human primate use, while informing sponsors’ development programs for cancer therapies.