FDA classifies diabetes digital behavioral therapeutic devices into class II with special controls to ensure safety and effectiveness.
US Federal Register - FDA Rules · United StatesFDA denied a petition for exemption from premarket notification requirements for radiology computer-aided detection, diagnosis, and triage software devices.
US Federal Register - FDA Rules · United StatesFDA classifies high throughput DNA sequencing for hereditary cancer predisposition assessment test systems into class II with special controls.
US Federal Register - FDA Rules · United StatesFDA classifies nucleic acid detection systems for non-viral STI pathogens from home-collected specimens into class II with special controls.
US Federal Register - FDA Rules · United StatesFDA classifies focused ultrasound systems for non-thermal mechanical tissue ablation into Class II with special controls.
US Federal Register - FDA Rules · United StatesFDA classifies hyperoxia monitoring device adjunct to pulse oximetry as Class II with special controls.
US Federal Register - FDA Rules · United StatesFDA classifies cardiovascular machine learning-based notification software as Class II with special controls.
US Federal Register - FDA Rules · United StatesFDA classifies hematopoietic cell enrichment kit as Class II with special controls.
US Federal Register - FDA Rules · United StatesFDA classifies infant pulse rate and oxygen saturation monitor for over-the-counter use into class II with special controls.
US Federal Register - FDA Rules · United StatesFDA exempts certain Class II clinical toxicology test systems from 510(k) premarket notification requirements, effective immediately.
US Federal Register - FDA Rules · United StatesFDA classifies flushing and storage solution for vascular autografts at room temperature as Class II with special controls.
US Federal Register - FDA Rules · United StatesFDA classifies the cooperative powered surgical assist device for ENT surgery into class II with special controls.
US Federal Register - FDA Rules · United StatesFDA proposes reclassifying diagnostic endoscopic light source systems from class III to class II with special controls and a new regulatory name.
US Federal Register - FDA Rules · United StatesFDA reclassifies in situ hybridization test systems for oncology therapeutics from class III to class II, establishing special controls and premarket notification requirements.
US Federal Register - FDA Rules · United StatesFDA proposes reclassifying digital breast tomosynthesis systems from class III to class II, subject to special controls and premarket notification.
US Federal Register - FDA Rules · United StatesFDA classifies fludeoxyglucose F18-guided radiation therapy system as Class II with special controls.
US Federal Register - FDA Rules · United StatesFDA classifies over-the-counter SARS-CoV-2 test from clinical specimens as Class II with special controls.
US Federal Register - FDA Rules · United StatesFDA classifies prognostic test for chronic kidney disease progression assessment into class II with special controls.
US Federal Register - FDA Rules · United StatesFDA classifies computerized behavioral therapy device for fibromyalgia into class II with special controls.
US Federal Register - FDA Rules · United StatesFDA classifies radiological machine learning-based quantitative imaging software with predetermined change control plan as Class II with special controls.
US Federal Register - FDA Rules · United StatesFDA classifies temperature regulation device for esophageal protection during cardiac ablation into class II with special controls.
US Federal Register - FDA Rules · United StatesFDA classifies the implanted tibial electrical urinary continence device into class II with special controls.
US Federal Register - FDA Rules · United StatesFDA classifies vaginal hydrogel packing system as Class II device subject to special controls.
US Federal Register - FDA Rules · United StatesFDA classifies the mechanical deviation device for esophageal protection during cardiac ablation procedures into class II with special controls.
US Federal Register - FDA Rules · United StatesFDA classifies extravascular support for arteriovenous fistula for vascular access into class II with special controls.
US Federal Register - FDA Rules · United StatesFDA classifies phase-changing fiducial marker for radiation therapy as Class II with special controls.
US Federal Register - FDA Rules · United StatesFDA classifies the intraoperative surgical angle measurement tool into class II with special controls.
US Federal Register - FDA Rules · United StatesFDA classifies whole room microbial reduction devices into class II with special controls.
US Federal Register - FDA Rules · United StatesFDA classifies anti-TNF alpha monoclonal antibody test system for inflammatory bowel disease into class II with special controls.
US Federal Register - FDA Rules · United StatesFDA classifies active noise attenuation systems for infant incubators as Class II devices subject to special controls.
US Federal Register - FDA Rules · United StatesFDA classifies simple point-of-care SARS-CoV-2 detection devices into class II with special controls.
US Federal Register - FDA Rules · United StatesFDA classifies non-medicated topical formulation for erectile dysfunction treatment as Class II with special controls.
US Federal Register - FDA Rules · United StatesFDA classifies SARS-CoV-2 serology test as Class II device with special controls.
US Federal Register - FDA Rules · United StatesFDA classifies prognostic test for preeclampsia development or progression into class II with special controls.
US Federal Register - FDA Rules · United StatesFDA classifies simple in vitro diagnostic devices for detection of secreted proteins from Bacillus species in human clinical samples into class II with special controls.
US Federal Register - FDA Rules · United StatesFDA classifies ingestible gastrointestinal blood detection capsule into class II with special controls.
US Federal Register - FDA Rules · United StatesFDA classifies Spinal Muscular Atrophy newborn screening test system as Class II with special controls.
US Federal Register - FDA Rules · United StatesFDA classifies real-time ultrasound anatomy visualization and labeling device for ultrasound-guided regional anesthesia into Class II with special controls.
US Federal Register - FDA Rules · United StatesFDA classifies monitor for opioid-induced impairment of oxygenation into Class II with special controls.
US Federal Register - FDA Rules · United StatesFDA classifies skin patch for hyperhidrosis treatment into class II with special controls.
US Federal Register - FDA Rules · United StatesFDA classifies medial knee implanted shock absorber as Class II with special controls.
US Federal Register - FDA Rules · United StatesFDA classifies the infant supine sleep system as Class II with special controls to ensure safety and effectiveness.
US Federal Register - FDA Rules · United StatesFDA classifies external lower extremity nerve stimulator for Restless Legs Syndrome as Class II with special controls.
US Federal Register - FDA Rules · United StatesFDA classifies the endoscopic traction device into class II with special controls.
US Federal Register - FDA Rules · United StatesFDA classifies the endoscopic light-projecting measuring device into class II with special controls.
US Federal Register - FDA Rules · United StatesFDA classifies combined acoustic and electrical external stimulation device for tinnitus relief into class II with special controls.
US Federal Register - FDA Rules · United StatesFDA classifies resorbable calcium salt bone void filler with aminoglycoside antibacterial into class II with special controls.
US Federal Register - FDA Rules · United StatesFDA classifies shoulder joint humeral ceramic head/metallic stem prosthesis into Class II with special controls.
US Federal Register - FDA Rules · United StatesFDA classifies absorbable metallic bone fixation fasteners into class II with special controls.
US Federal Register - FDA Rules · United StatesFDA classifies adjunctive pain measurement devices for anesthesiology as Class II with special controls.
US Federal Register - FDA Rules · United States