{"source":"reg-medical-devices","note":"Free 5-item preview. The full feed is $0.05/call at GET /v1/reg-medical-devices/changes.","question":"Which final or proposed federal rules affecting medical devices were published since T, and which carry compliance obligations?","sample":[{"source":"reg-medical-devices","entityId":"fedreg:2026-10894","type":"final_rule","title":"Medical Devices; Ear, Nose, and Throat Devices; Classification of the Oropharyngeal Electrical Stimulator","summary":"The Food and Drug Administration (FDA) is classifying the oropharyngeal electrical stimulator into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the oropharyngeal electrical stimulator. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing …","significance":6,"detectedAt":"2026-07-14T22:19:03.390Z","effectiveDate":"2026-06-01","sourceUrl":"https://www.federalregister.gov/documents/2026/06/01/2026-10894/medical-devices-ear-nose-and-throat-devices-classification-of-the-oropharyngeal-electrical","detail":{"documentNumber":"2026-10894","documentType":"Rule","agencies":"Health and Human Services Department, Food and Drug Administration","publicationDate":"2026-06-01","vertical":"reg-medical-devices"}},{"source":"reg-medical-devices","entityId":"fedreg:2026-10898","type":"final_rule","title":"Medical Devices; Hematology and Pathology Devices; Classification of the Von Willebrand Factor Assay","summary":"The Food and Drug Administration (FDA) is classifying the von Willebrand factor assay into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the von Willebrand factor assay. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burde…","significance":6,"detectedAt":"2026-07-14T22:19:03.390Z","effectiveDate":"2026-06-01","sourceUrl":"https://www.federalregister.gov/documents/2026/06/01/2026-10898/medical-devices-hematology-and-pathology-devices-classification-of-the-von-willebrand-factor-assay","detail":{"documentNumber":"2026-10898","documentType":"Rule","agencies":"Health and Human Services Department, Food and Drug Administration","publicationDate":"2026-06-01","vertical":"reg-medical-devices"}},{"source":"reg-medical-devices","entityId":"fedreg:2026-10899","type":"final_rule","title":"Medical Devices; Dental Devices; Classification of the Intraoral Cooling Device","summary":"The Food and Drug Administration (FDA) is classifying the intraoral cooling device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the intraoral cooling device. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.","significance":6,"detectedAt":"2026-07-14T22:19:03.390Z","effectiveDate":"2026-06-01","sourceUrl":"https://www.federalregister.gov/documents/2026/06/01/2026-10899/medical-devices-dental-devices-classification-of-the-intraoral-cooling-device","detail":{"documentNumber":"2026-10899","documentType":"Rule","agencies":"Health and Human Services Department, Food and Drug Administration","publicationDate":"2026-06-01","vertical":"reg-medical-devices"}},{"source":"reg-medical-devices","entityId":"fedreg:2026-10904","type":"final_rule","title":"Medical Devices; Gastroenterology-Urology Devices; Classification of the Orally Ingested Transient Device for Constipation","summary":"The Food and Drug Administration (FDA) is classifying the orally ingested transient device for constipation into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the orally ingested transient device for constipation. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative d…","significance":6,"detectedAt":"2026-07-14T22:19:03.390Z","effectiveDate":"2026-06-01","sourceUrl":"https://www.federalregister.gov/documents/2026/06/01/2026-10904/medical-devices-gastroenterology-urology-devices-classification-of-the-orally-ingested-transient","detail":{"documentNumber":"2026-10904","documentType":"Rule","agencies":"Health and Human Services Department, Food and Drug Administration","publicationDate":"2026-06-01","vertical":"reg-medical-devices"}},{"source":"reg-medical-devices","entityId":"fedreg:2026-10905","type":"final_rule","title":"Medical Devices; Anesthesiology Devices; Classification of the Adjunctive Pain Measurement Device for Anesthesiology","summary":"The Food and Drug Administration (FDA) is classifying the adjunctive pain measurement device for anesthesiology into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the adjunctive pain measurement device for anesthesiology. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial inno…","significance":6,"detectedAt":"2026-07-14T22:19:03.390Z","effectiveDate":"2026-06-01","sourceUrl":"https://www.federalregister.gov/documents/2026/06/01/2026-10905/medical-devices-anesthesiology-devices-classification-of-the-adjunctive-pain-measurement-device-for","detail":{"documentNumber":"2026-10905","documentType":"Rule","agencies":"Health and Human Services Department, Food and Drug Administration","publicationDate":"2026-06-01","vertical":"reg-medical-devices"}}]}