Medical Device Classification (FDA)

Current understanding

To be populated as evidence accumulates.

Evidence log

• 2026-11-05 — Medical Devices; Orthopedic Devices; Classification of the Wearable Vibration Device for Orthopedic Use: FDA’s final classification order places wearable vibration devices for orthopedic use in Class II with special controls intended to provide reasonable assurance of safety and effectiveness, enabling future manufacturers of similar devices to seek 510(k) market clearance. (novelty: 2)
• 2026-11-05 — Medical Devices; Neurological Devices; Classification of the Prognostic Assessment Software of Mild Cognitive Impairment: FDA final rule classifies prognostic assessment software for mild cognitive impairment as a Class II neurological device subject to special controls, establishing a standardized market-clearance pathway for software used in patient prognostic assessment. (novelty: 2)
• 2026-11-05 — Medical Devices; Hematology and Pathology Devices; Classification of the Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm: FDA final rule classifies digital cervical cytology slide imaging systems with artificial intelligence algorithms as Class II hematology and pathology devices subject to special controls, enabling manufacturers of similar systems to seek 510(k) clearance for tools used in cervical cytology workflows. (novelty: 2)
• 2026-11-06 — Medical Devices; Ear, Nose, and Throat Devices; Classification of the External Mechanical Stimulator for the Relief of Congestion: FDA final rule classifies external mechanical stimulators for congestion relief as Class II ear, nose, and throat devices, requiring manufacturers to meet device-specific special controls intended to provide reasonable assurance of safety and effectiveness. (novelty: 2)
• 2026-10-09 — Medical Devices; Immunology and Microbiology Devices; Classification of the Hematopoietic Cell Enrichment Kit: FDA final rule classifies the hematopoietic cell enrichment kit as a Class II device (immunology and microbiology) subject to special controls, establishing a 510(k) pathway in place of Class III PMA review. (novelty: 2)
• 2026-10-09 — Medical Devices; Cardiovascular Devices; Classification of the Infant Pulse Rate and Oxygen Saturation Monitor for Over-the-Counter Use: FDA final rule classifies the over-the-counter infant pulse rate and oxygen saturation monitor as a Class II cardiovascular device subject to special controls, establishing a 510(k) pathway in place of Class III PMA review. (novelty: 2)
• 2026-10-09 — Medical Devices; Immunology and Microbiology Devices; Classification of the System for Detection of Nucleic Acid From Non-Viral Microorganism(s) Causing Sexually Transmitted Infections Using Home-Collected Specimens: FDA final rule classifies systems for detection of nucleic acid from non-viral microorganisms causing sexually transmitted infections using home-collected specimens as a Class II device (immunology and microbiology) subject to special controls, establishing a 510(k) pathway intended to ease market entry for at-home STI testing. (novelty: 2)
• 2026-10-30 — Medical Devices; General and Plastic Surgery Devices; Classification of the Software-Aided Adjunctive Diagnostic Device for Use by Physicians on Lesions Suspicious for Skin Cancer: FDA final rule classifies the software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer as a Class II device (general and plastic surgery) subject to special controls, establishing a 510(k) pathway intended to ease market entry. (novelty: 2)
• 2026-10-30 — Medical Devices; Radiology Devices; Classification of the Radiology Software for Referral of Findings Related to Fibrotic Lung Disease: FDA final rule classifies radiology software for referral of findings related to fibrotic lung disease as a Class II device subject to special controls, establishing a 510(k) pathway in place of Class III PMA review. (novelty: 2)
• 2026-10-30 — Medical Devices; Anesthesiology Devices; Classification of the Spinal Imaging System for Neuraxial Procedures: FDA final rule classifies the spinal imaging system for neuraxial procedures as a Class II anesthesiology device subject to special controls, establishing a 510(k) pathway intended to ease market entry while providing reasonable assurance of safety and effectiveness. (novelty: 2)
• 2026-10-30 — Medical Devices; Anesthesiology Devices; Classification of the Over-the-Counter Device To Assess Risk of Sleep Apnea: FDA final rule classifies the over-the-counter device to assess risk of sleep apnea as a Class II device (anesthesiology) subject to special controls, establishing a 510(k) pathway in place of Class III PMA review. (novelty: 2)
• 2026-09-30 — Medical Devices; Gastroenterology-Urology Devices; Classification of the Flushing and Storage Solution for Vascular Autografts at Room Temperature: FDA final rule classifies the flushing and storage solution for vascular autografts at room temperature as a Class II device (gastroenterology-urology) subject to special controls, establishing a 510(k) pathway in place of Class III PMA review. (novelty: 2)
• 2026-10-06 — Medical Devices; General and Plastic Surgery Devices; Classification of the Focused Ultrasound System for Non-Thermal, Mechanical Tissue Ablation: FDA final rule classifies the focused ultrasound system for non-thermal, mechanical tissue ablation as a Class II device (general and plastic surgery) subject to special controls, establishing a 510(k) pathway in place of Class III PMA review. (novelty: 2)
• 2026-10-06 — Medical Devices; Cardiovascular Devices; Classification of the Hyperoxia Monitoring Device Adjunct to Pulse Oximetry: FDA final rule classifies the hyperoxia monitoring device adjunct to pulse oximetry as a Class II cardiovascular device subject to special controls, establishing a 510(k) pathway intended to reduce regulatory burdens on manufacturers. (novelty: 2)
• 2026-10-06 — Medical Devices; Immunology and Microbiology Devices; Classification of the High Throughput DNA Sequencing for Hereditary Cancer Predisposition Assessment Test System: FDA final rule classifies the high-throughput DNA sequencing test system for hereditary cancer predisposition assessment as a Class II device (immunology and microbiology) subject to special controls, establishing a 510(k) pathway in place of Class III PMA review. (novelty: 2)
• 2026-10-06 — Medical Devices; Exemptions From Premarket Notification: Class II Devices; Certain Clinical Toxicology Test Systems: FDA final rule exempts certain Class II clinical toxicology test systems from 510(k) premarket notification, subject to listed limitations, allowing manufacturers to market those devices without prior FDA filing. (novelty: 2)
• 2026-09-10 — Medical Devices; General Hospital and Personal Use Devices; Classification of the Whole Room Microbial Reduction Device: FDA final rule classifies the whole-room microbial reduction device as a Class II device (general hospital and personal use) subject to special controls, establishing a 510(k) pathway intended to reduce regulatory burdens on manufacturers. (novelty: 2)
• 2026-09-10 — Medical Devices; Radiology Devices; Classification of the Vaginal Hydrogel Packing System: FDA final rule classifies the vaginal hydrogel packing system as a Class II device (radiology) subject to special controls, establishing a 510(k) pathway intended to reduce regulatory burdens on manufacturers. (novelty: 2)
• 2026-09-10 — Medical Devices; Gastroenterology-Urology Devices; Classification of the Implanted Tibial Electrical Urinary Continence Device: FDA final rule classifies the implanted tibial electrical urinary continence device as a Class II device (gastroenterology-urology) subject to special controls, establishing a 510(k) pathway intended to ease market entry for similar implanted tibial neurostimulators for urinary continence. (novelty: 2) (novelty: 2)
• 2026-09-10 — Medical Devices; Ear, Nose, and Throat Devices; Classification of the Cooperative Powered Surgical Assist Device for ENT Surgery: FDA final rule classifies the cooperative powered surgical assist device for ENT surgery as a Class II device (ear, nose, and throat) subject to special controls, establishing a 510(k) pathway in place of Class III PMA review. (novelty: 2)
• 2026-09-10 — Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Anti-Tumor Necrosis Factor Alpha Monoclonal Antibody Test System for Inflammatory Bowel Disease: FDA final rule classifies the anti-tumor necrosis factor alpha monoclonal antibody test system for inflammatory bowel disease as a Class II device (clinical chemistry and clinical toxicology) subject to special controls, establishing a 510(k) pathway in place of Class III PMA review. (novelty: 2)
• 2026-09-10 — Medical Devices; Cardiovascular Devices; Classification of the Extravascular Support for an Arteriovenous Fistula for Vascular Access: FDA final rule classifies the extravascular support for an arteriovenous fistula for vascular access as a Class II cardiovascular device subject to special controls, establishing a 510(k) pathway in place of Class III PMA review for similar dialysis fistula support devices. (novelty: 2)
• 2026-09-10 — Medical Devices; Cardiovascular Devices; Classification of the Temperature Regulation Device for Esophageal Protection During Cardiac Ablation Procedures: FDA final rule classifies the temperature regulation device for esophageal protection during cardiac ablation as a Class II cardiovascular device subject to special controls, establishing a 510(k) pathway in place of the Class III PMA process. (novelty: 2)
• 2026-09-10 — Medical Devices; Cardiovascular Devices; Classification of the Mechanical Deviation Device for Esophageal Protection During Cardiac Ablation Procedures: FDA final rule classifies the mechanical deviation device for esophageal protection during cardiac ablation as a Class II cardiovascular device subject to special controls, establishing a 510(k) pathway intended to ease market entry while providing reasonable assurance of safety and effectiveness. (novelty: 2)
• 2026-09-11 — Medical Devices; Cardiovascular Devices; Classification of the Cardiovascular Machine Learning-Based Notification Software: FDA final rule classifies cardiovascular machine learning-based notification software as a Class II device (cardiovascular) subject to special controls, intended to provide reasonable assurance of safety and effectiveness while reducing regulatory burdens on manufacturers. (novelty: 2)
• 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

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