Medical Device Classification (FDA)

Current understanding

To be populated as evidence accumulates.

Evidence log

• 2026-08-17 — Hematology and Pathology Devices; Reclassification of In Situ Hybridization Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product: FDA final rule reclassifies in situ hybridization test systems used as companion diagnostics with approved oncology therapeutics from Class III (PMA) to Class II with special controls (510(k)), easing market entry for that companion-diagnostic device niche. (novelty: 3)
• 2026-08-17 — Gastroenterology-Urology Devices; Reclassification of Diagnostic Endoscopic Light Source Systems To Be Renamed Cystoscopic Systems Intended as an Aid for Detection of Bladder Cancer: FDA proposed rule would reclassify certain diagnostic endoscopic light source systems (to be renamed cystoscopic systems intended as an aid for detection of bladder cancer) from Class III (PMA) to Class II with special controls and 510(k) notification, creating a new device classification regulation. (novelty: 2)
• 2026-08-17 — Medical Devices; Classification of Accessories Distinct From Other Devices; Proposed List of Accessories Suitable for Class I; Request for Comments: FDA proposed rule would classify a listed set of medical device accessories as Class I (general controls only) distinct from their parent devices under the FDARA accessory-classification process, with a public comment period preceding any final determination. (novelty: 2)
• 2026-08-06 — Medical Devices; Radiology Devices; Classification of the Fludeoxyglucose F18-Guided Radiation Therapy System: FDA final rule classifies the fludeoxyglucose F18-guided radiation therapy system as a Class II device (radiology) subject to special controls, intended to provide reasonable assurance of safety and effectiveness while reducing regulatory burdens on manufacturers. (novelty: 2)
• 2025-06-03 — VALID Act of 2025: VALID Act of 2025 (HR3694) introduced in the 119th Congress would create a separate FDA framework for in vitro clinical tests (including LDTs), potentially carving diagnostic tests out of the existing medical device classification pathway. (novelty: 2)
• 2026-07-29 — Medical Devices; Radiology Devices; Classification of the Phase-Changing Fiducial Marker for Radiation Therapy: FDA final rule classifies the phase-changing fiducial marker for radiation therapy as a Class II device (radiology) subject to special controls, intended to provide reasonable assurance of safety and effectiveness while reducing regulatory burdens on manufacturers. (novelty: 2)
• 2026-07-24 — Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Prognostic Test for Assessment of Chronic Kidney Disease Progression: FDA final rule classifies the prognostic test for assessment of chronic kidney disease progression as a Class II device (clinical chemistry and clinical toxicology) subject to special controls, intended to provide reasonable assurance of safety and effectiveness while reducing regulatory burdens on manufacturers. (novelty: 2) (novelty: 2)
• 2026-07-24 — Medical Devices; Immunology and Microbiology Devices; Classification of the Over-the-Counter Test To Detect SARS-CoV-2 From Clinical Specimens: FDA final rule classifies over-the-counter tests to detect SARS-CoV-2 from clinical specimens as a Class II device (immunology and microbiology) subject to special controls, intended to provide reasonable assurance of safety and effectiveness while reducing regulatory burdens and improving access. (novelty: 2)
• 2026-07-24 — Medical Devices; General Hospital and Personal Use Devices; Classification of the Diabetes Digital Behavioral Therapeutic Device: FDA final rule classifies the diabetes digital behavioral therapeutic device as a Class II device (general hospital and personal use) subject to special controls, intended to provide reasonable assurance of safety and effectiveness while reducing regulatory burdens and improving patient access. (novelty: 2) (novelty: 2)
• 2026-07-27 — Medical Devices; Gastroenterology-Urology Devices; Classification of the Non-Medicated Topical Formulation for Treatment of Erectile Dysfunction: FDA final rule classifies non-medicated topical formulations for treatment of erectile dysfunction as a Class II device (gastroenterology-urology) subject to special controls, intended to provide reasonable assurance of safety and effectiveness while reducing regulatory burdens on manufacturers. (novelty: 2) (novelty: 2)
• 2026-07-27 — Medical Devices; General Hospital and Personal Use Devices; Classification of the Active Noise Attenuation System for Infant Incubators: FDA final rule classifies the active noise attenuation system for infant incubators as a Class II device (general hospital and personal use) subject to special controls, intended to provide reasonable assurance of safety and effectiveness while reducing regulatory burdens on manufacturers. (novelty: 2)
• 2026-06-18 — Destruction of Hazardous Imports Act: 2026 — Destruction of Hazardous Imports Act (citation removed): Introduced bill would give FDA authority to order destruction (no export option) of refused imported medical devices deemed a significant public health concern, with criminal penalties for unauthorized movement. (novelty: 3) (novelty: 3)
• 2025-11-18 — Patient Device Data Access Act of 2025: cross-connection with health-data-access-transparency-affordability: HR6117 links patient health data access rights to FDA-regulated medical devices, connecting the data transparency policy area with the device regulatory framework. (novelty: 2)
• 2026-05-08 — Medical Devices; Obstetrical and Gynecological Devices; Classification of the External Condom for Anal Intercourse or Vaginal Intercourse: FDA final rule classifies external condoms for anal intercourse or vaginal intercourse as Class II devices (obstetrical and gynecological) subject to special controls, intended to provide reasonable assurance of safety and effectiveness while reducing regulatory burdens on manufacturers. (novelty: 2) (novelty: 2)
• 2026-05-12 — Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Microorganism Nucleic Acids and Resistance Markers From Patients With Suspected Orthopedic Infection: FDA final rule classifies devices that detect and identify microorganism nucleic acids and resistance markers from patients with suspected orthopedic infection as a Class II device (immunology and microbiology) subject to special controls, intended to provide reasonable assurance of safety and effectiveness while reducing regulatory burdens on manufacturers. (novelty: 2)
• 2026-05-28 — Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Suturing Device for Altering Gastric Anatomy for Weight Loss: FDA final rule classifies the endoscopic suturing device for altering gastric anatomy for weight loss as a Class II device (gastroenterology-urology) subject to special controls, intended to provide reasonable assurance of safety and effectiveness while enhancing patient access. (novelty: 2)
• 2026-05-29 — Medical Devices; Neurological Devices; Classification of the Transcutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms: FDA final rule classifies the transcutaneous electrical nerve stimulator for fibromyalgia symptoms as a Class II neurological device subject to special controls, intended to provide reasonable assurance of safety and effectiveness while enhancing patient access. (novelty: 2) (novelty: 2)
• 2026-06-01 — Medical Devices; Ear, Nose, and Throat Devices; Classification of the Oropharyngeal Electrical Stimulator: FDA final rule classifies the oropharyngeal electrical stimulator as a Class II device (ear, nose, and throat) subject to special controls, intended to provide reasonable assurance of safety and effectiveness while reducing regulatory burdens on manufacturers. (novelty: 2)
• 2026-06-01 — Medical Devices; Hematology and Pathology Devices; Classification of the Von Willebrand Factor Assay: FDA final rule classifies the von Willebrand factor assay (hematology and pathology) as a Class II device subject to special controls, intended to provide reasonable assurance of safety and effectiveness while reducing regulatory burdens on manufacturers. (novelty: 2)
• 2026-06-01 — Medical Devices; Dental Devices; Classification of the Intraoral Cooling Device: FDA final rule classifies the intraoral cooling device as a Class II dental device subject to special controls, intended to provide reasonable assurance of safety and effectiveness while reducing regulatory burdens on manufacturers. (novelty: 2)
• 2026-06-01 — Medical Devices; Gastroenterology-Urology Devices; Classification of the Orally Ingested Transient Device for Constipation: FDA final rule classifies the orally ingested transient device for constipation as a Class II device (gastroenterology-urology) subject to special controls, intended to provide reasonable assurance of safety and effectiveness while reducing regulatory burdens on manufacturers. (novelty: 2)
• 2026-06-01 — Medical Devices; Anesthesiology Devices; Classification of the Adjunctive Pain Measurement Device for Anesthesiology: 2026-06-26 — Medical Devices; Anesthesiology Devices; Classification of the Adjunctive Pain Measurement Device for Anesthesiology: FDA final rule classifies the adjunctive pain measurement device for anesthesiology as a Class II device subject to special controls, intended to provide reasonable assurance of safety and effectiveness while reducing regulatory burdens and enhancing patient access. (novelty: 2) (novelty: 2)
• 2026-06-01 — Medical Devices; Anesthesiology Devices; Classification of the Real-Time Ultrasound Anatomy Visualization and Labeling Device for Ultrasound Guided Regional Anesthesia: FDA final rule classifies the real-time ultrasound anatomy visualization and labeling device for ultrasound-guided regional anesthesia as a Class II device (anesthesiology) subject to special controls, intended to provide reasonable assurance of safety and effectiveness while reducing regulatory burdens on manufacturers. (novelty: 2) (novelty: 2)
• 2026-06-01 — Medical Devices; General Hospital and Personal Use Devices; Classification of the Rigid Sterilization Container With Electronic Monitoring: FDA final rule classifies the rigid sterilization container with electronic monitoring as a Class II device (general hospital and personal use) subject to special controls, intended to provide reasonable assurance of safety and effectiveness while reducing regulatory burdens on manufacturers. (novelty: 2)
• 2026-06-05 — Medical Devices; Orthopedic Devices; Classification of the Absorbable Metallic Bone Fixation Fastener: FDA final rule classifies the absorbable metallic bone fixation fastener as a Class II device (orthopedic) subject to special controls, intended to provide reasonable assurance of safety and effectiveness while reducing regulatory burdens on manufacturers. (novelty: 2)
• 2026-06-05 — Medical Devices; Orthopedic Devices; Classification of the Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented or Uncemented Prosthesis: FDA final rule classifies the shoulder joint humeral (hemi-shoulder) ceramic head/metallic stem cemented or uncemented prosthesis as a Class II device (orthopedic) subject to special controls, intended to provide reasonable assurance of safety and effectiveness while reducing regulatory burdens on manufacturers. (novelty: 2)
• 2026-06-05 — Medical Devices; Orthopedic Devices; Classification of the Resorbable Calcium Salt Bone Void Filler Containing a Single Approved Aminoglycoside Antibacterial: FDA final rule classifies the resorbable calcium salt bone void filler containing a single approved aminoglycoside antibacterial as a Class II device (orthopedic) subject to special controls, intended to provide reasonable assurance of safety and effectiveness. (novelty: 2)
• 2026-06-10 — Medical Devices; Ear, Nose, and Throat Devices; Classification of the Combined Acoustic and Electrical External Stimulation Device for the Relief of Tinnitus: 2026-06-26 — Medical Devices; Ear, Nose, and Throat Devices; Classification of the Combined Acoustic and Electrical External Stimulation Device for the Relief of Tinnitus: FDA final rule classifies the combined acoustic and electrical external stimulation device for tinnitus relief as a Class II device subject to special controls, establishing a regulatory pathway intended to reduce burdens on manufacturers and enhance patient access. (novelty: 3) (novelty: 3)
• 2026-06-11 — Medical Devices; Immunology and Microbiology Devices; Classification of the Simple Point-of-Care Device to Directly Detect SARS-CoV-2 Viral Targets From Clinical Specimens in Near-Patient Settings: FDA final rule classifies the simple point-of-care device that directly detects SARS-CoV-2 viral targets from clinical specimens in near-patient settings as a Class II device subject to special controls, intended to provide reasonable assurance of safety and effectiveness while reducing regulatory burdens on manufacturers. (novelty: 2)
• 2026-06-11 — Medical Devices; Immunology and Microbiology Devices; Classification of the Spinal Muscular Atrophy Newborn Screening Test System: FDA final rule classifies the Spinal Muscular Atrophy newborn screening test system as a Class II device subject to special controls, intended to provide reasonable assurance of safety and effectiveness while reducing regulatory burdens and enhancing patient access. (novelty: 2)
• 2026-06-17 — Medical Devices; Gastroenterology-Urology Devices; Classification of the Ingestible Gastrointestinal Blood Detection Capsule: FDA final rule classifies the ingestible gastrointestinal blood detection capsule as a Class II device subject to special controls, intended to provide reasonable assurance of safety and effectiveness while enhancing patient access. (novelty: 3)
• 2026-06-17 — Medical Devices; Radiology Devices; Classification of the Radiological Machine Learning-Based Quantitative Imaging Software With Predetermined Change Control Plan: FDA final rule classifies radiological machine learning-based quantitative imaging software with a predetermined change control plan as a Class II device subject to special controls, establishing a first-of-its-kind regulatory pathway that permits pre-authorized algorithm modifications without new submissions. (novelty: 3) (novelty: 3)
• 2026-06-22 — Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Traction Device: FDA final rule classifies the endoscopic traction device (gastroenterology-urology) as a Class II device subject to special controls, intended to provide reasonable assurance of safety and effectiveness while reducing regulatory burdens on manufacturers. (novelty: 2)
• 2026-06-26 — Medical Devices; Clinical Chemistry and Toxicology Devices; Classification of the Prognostic Test for Development or Progression of Preeclampsia: FDA final rule classifies the prognostic test for development or progression of preeclampsia as a Class II device subject to special controls, intended to provide reasonable assurance of safety and effectiveness while enhancing patient access. (novelty: 3)
• 2026-06-26 — Medical Devices; Neurological Devices; Classification of the Computerized Behavioral Therapy Device for the Treatment of Fibromyalgia Symptoms: FDA final rule classifies the computerized behavioral therapy device for fibromyalgia symptoms as a Class II device subject to special controls, intended to provide reasonable assurance of safety and effectiveness while improving patient access. (novelty: 3)
• 2026-06-26 — Medical Devices; Immunology and Microbiology Devices; Classification of the SARS-CoV-2 Serology Test: FDA final rule classifies the SARS-CoV-2 serology test as a Class II device subject to special controls, intended to provide reasonable assurance of safety and effectiveness while reducing regulatory burdens on manufacturers. (novelty: 2)
• 2026-06-26 — Medical Devices; General and Plastic Surgery Devices; Classification of the Breast Implant Suction Retrieval System: FDA final rule classifies the breast implant suction retrieval system as a Class II device subject to special controls, intended to provide reasonable assurance of safety and effectiveness while reducing regulatory burdens on manufacturers. (novelty: 2)
• 2026-06-26 — Medical Devices; Neurological Devices; Classification of the External Lower Extremity Nerve Stimulator for Restless Legs Syndrome: FDA final rule classifies the external lower extremity nerve stimulator for Restless Legs Syndrome as a Class II device subject to special controls, intended to provide reasonable assurance of safety and effectiveness while enhancing patient access. (novelty: 2)
• 2026-06-26 — Medical Devices; General Hospital and Personal Use Devices; Classification of the Infant Supine Sleep System: FDA final rule classifies the infant supine sleep system as a Class II device subject to special controls, aiming to provide reasonable assurance of safety and effectiveness while reducing regulatory burdens on manufacturers. (novelty: 2)

Open questions

Related