Nonclinical Testing Terminology
FDA proposes to substitute 'animal' with 'nonclinical' in safety and reporting regulations and align terminology with recent statutory amendments.
US Federal Register - FDA Rules · United StatesUS Federal Register - FDA Rules
Regulation
Category
Type
Date
Nonclinical Testing Terminology
FDA substitutes 'nonclinical' for 'animal', 'preclinical', and 'in vitro' in safety and reporting regulations to align with statutory amendments and encourage alternative testing methodologies.
US Federal Register - FDA Rules · United StatesUse of Salt Substitutes To Reduce the Sodium Content in Standardized Foods
FDA permits salt substitutes in standardized foods to reduce sodium content and support cardiovascular health.
US Federal Register - FDA Rules · United StatesMedical Devices; General Hospital and Personal Use Devices; Classification of the Diabetes Digital Behavioral Therapeutic Device
FDA classifies diabetes digital behavioral therapeutic devices into class II with special controls to ensure safety and effectiveness.
US Federal Register - FDA Rules · United StatesMedical Devices; Exemption From Premarket Notification: Radiology Computer-Aided Detection and/or Diagnosis Devices and Computer-Aided Triage and Notification Devices
FDA 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 StatesMedical Devices; Immunology and Microbiology Devices; Classification of the High Throughput DNA Sequencing for Hereditary Cancer Predisposition Assessment Test System
FDA classifies high throughput DNA sequencing for hereditary cancer predisposition assessment test systems into class II with special controls.
US Federal Register - FDA Rules · United StatesRequirements for Additional Traceability Records for Certain Foods: Enforcement Policy for Certain Retail Food Establishments and Restaurants; Draft Guidance for Industry
FDA announces draft guidance stating it does not intend to enforce certain traceability record requirements for specified retail food establishments and restaurants.
US Federal Register - FDA Rules · United StatesMedical 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 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 StatesMedical Devices; Cardiovascular Devices; Classification of the Hyperoxia Monitoring Device Adjunct to Pulse Oximetry
FDA classifies hyperoxia monitoring device adjunct to pulse oximetry as Class II with special controls.
US Federal Register - FDA Rules · United StatesMedical Devices; General and Plastic Surgery Devices; Classification of the Focused Ultrasound System for Non-Thermal, Mechanical Tissue Ablation
FDA classifies focused ultrasound systems for non-thermal mechanical tissue ablation into Class II with special controls.
US Federal Register - FDA Rules · United StatesMedical Devices; Cardiovascular Devices; Classification of the Cardiovascular Machine Learning-Based Notification Software
FDA classifies cardiovascular machine learning-based notification software as Class II with special controls.
US Federal Register - FDA Rules · United StatesMedical Devices; Cardiovascular Devices; Classification of the Infant Pulse Rate and Oxygen Saturation Monitor for Over-the-Counter Use
FDA 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 StatesMedical Devices; Immunology and Microbiology Devices; Classification of the Hematopoietic Cell Enrichment Kit
FDA classifies hematopoietic cell enrichment kit as Class II with special controls.
US Federal Register - FDA Rules · United StatesMedical Devices; Exemptions From Premarket Notification: Class II Devices; Certain Clinical Toxicology Test Systems
FDA exempts certain Class II clinical toxicology test systems from 510(k) premarket notification requirements, effective immediately.
US Federal Register - FDA Rules · United StatesMedical Devices; Gastroenterology-Urology Devices; Classification of the Flushing and Storage Solution for Vascular Autografts at Room Temperature
FDA classifies flushing and storage solution for vascular autografts at room temperature as Class II with special controls.
US Federal Register - FDA Rules · United StatesMedical Devices; Ear, Nose, and Throat Devices; Classification of the Cooperative Powered Surgical Assist Device for ENT Surgery
FDA classifies the cooperative powered surgical assist device for ENT surgery into class II with special controls.
US Federal Register - FDA Rules · United StatesReclassification of Diagnostic Endoscopic Light Source Systems to Cystoscopic Systems Intended as an Aid for Detection of Bladder Cancer
FDA 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 StatesHematology and Pathology Devices; Reclassification of In Situ Hybridization Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product
FDA 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 StatesRadiology Devices; Reclassification of Digital Breast Tomosynthesis System
FDA 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 StatesMedical Devices; Radiology Devices; Classification of the Fludeoxyglucose F18-Guided Radiation Therapy System
FDA classifies fludeoxyglucose F18-guided radiation therapy system as Class II with special controls.
US Federal Register - FDA Rules · United StatesMedical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Prognostic Test for Assessment of Chronic Kidney Disease Progression
FDA classifies prognostic test for chronic kidney disease progression assessment into class II with special controls.
US Federal Register - FDA Rules · United StatesMedical Devices; Immunology and Microbiology Devices; Classification of the Over-the-Counter Test To Detect SARS-CoV-2 From Clinical Specimens
FDA classifies over-the-counter SARS-CoV-2 test from clinical specimens as Class II with special controls.
US Federal Register - FDA Rules · United StatesMedical Devices; Neurological Devices; Classification of the Computerized Behavioral Therapy Device for the Treatment of Fibromyalgia Symptoms
FDA classifies computerized behavioral therapy device for fibromyalgia into class II with special controls.
US Federal Register - FDA Rules · United StatesMedical Devices; Radiology Devices; Classification of the Radiological Machine Learning-Based Quantitative Imaging Software With Predetermined Change Control Plan
FDA 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 StatesMedical Devices; Cardiovascular Devices; Classification of the Mechanical Deviation Device for Esophageal Protection During Cardiac Ablation Procedures
FDA classifies the mechanical deviation device for esophageal protection during cardiac ablation procedures into class II with special controls.
US Federal Register - FDA Rules · United StatesMedical Devices; Cardiovascular Devices; Classification of the Temperature Regulation Device for Esophageal Protection During Cardiac Ablation Procedures
FDA classifies temperature regulation device for esophageal protection during cardiac ablation into class II with special controls.
US Federal Register - FDA Rules · United StatesMedical Devices; Cardiovascular Devices; Classification of the Extravascular Support for an Arteriovenous Fistula for Vascular Access
FDA classifies extravascular support for arteriovenous fistula for vascular access into class II with special controls.
US Federal Register - FDA Rules · United StatesMedical Devices; Gastroenterology-Urology Devices; Classification of the Implanted Tibial Electrical Urinary Continence Device
FDA classifies the implanted tibial electrical urinary continence device into class II with special controls.
US Federal Register - FDA Rules · United StatesMedical Devices; Radiology Devices; Classification of the Vaginal Hydrogel Packing System
FDA classifies vaginal hydrogel packing system as Class II device subject to special controls.
US Federal Register - FDA Rules · United StatesMedical Devices; Radiology Devices; Classification of the Phase-Changing Fiducial Marker for Radiation Therapy
FDA classifies phase-changing fiducial marker for radiation therapy as Class II with special controls.
US Federal Register - FDA Rules · United StatesMedical Devices; Orthopedic Devices; Classification of the Intraoperative Surgical Angle Measurement Tool
FDA classifies the intraoperative surgical angle measurement tool into class II with special controls.
US Federal Register - FDA Rules · United StatesModification of Certain Terminology in Title 21; Reopening of the Comment Period
FDA reopens comment period on proposed rule to replace 'gender' with 'sex' throughout Title 21 CFR to comply with Executive Order 14168.
US Federal Register - FDA Rules · United StatesMedical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Anti-Tumor Necrosis Factor Alpha Monoclonal Antibody Test System for Inflammatory Bowel Disease
FDA classifies anti-TNF alpha monoclonal antibody test system for inflammatory bowel disease into class II with special controls.
US Federal Register - FDA Rules · United StatesMedical Devices; General Hospital and Personal Use Devices; Classification of the Whole Room Microbial Reduction Device
FDA classifies whole room microbial reduction devices into class II with special controls.
US Federal Register - FDA Rules · United StatesMedical Devices; General Hospital and Personal Use Devices; Classification of the Active Noise Attenuation System for Infant Incubators
FDA classifies active noise attenuation systems for infant incubators as Class II devices subject to special controls.
US Federal Register - FDA Rules · United StatesGuide to Minimize Biological Hazards in Ready-to-Eat Fresh-Cut Produce
FDA issues final guidance on biological hazard controls for ready-to-eat fresh-cut produce manufacturers, superseding 2008 guidance.
US Federal Register - FDA Rules · United StatesConsultation on GRAS Notice Submission Requirements for Food Substances
FDA proposes to require submission of GRAS notices for human and animal food substances claimed to be generally recognized as safe under the FD&C Act.
US Federal Register - FDA Rules · United StatesMedical 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 classifies simple point-of-care SARS-CoV-2 detection devices into class II with special controls.
US Federal Register - FDA Rules · United StatesMedical Devices; Gastroenterology-Urology Devices; Classification of the Non-Medicated Topical Formulation for Treatment of Erectile Dysfunction
FDA classifies non-medicated topical formulation for erectile dysfunction treatment as Class II with special controls.
US Federal Register - FDA Rules · United StatesMedical Devices; Immunology and Microbiology Devices; Classification of the SARS-CoV-2 Serology Test
FDA classifies SARS-CoV-2 serology test as Class II device with special controls.
US Federal Register - FDA Rules · United StatesMedical Devices; Clinical Chemistry and Toxicology Devices; Classification of the Prognostic Test for Development or Progression of Preeclampsia
FDA classifies prognostic test for preeclampsia development or progression into class II with special controls.
US Federal Register - FDA Rules · United StatesMedical Devices; Immunology and Microbiology Devices; Classification of the Simple In Vitro Diagnostic Device for the Detection of Secreted Proteins From Bacillus Species (spp.) in Human Clinical Samples
FDA 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 StatesMedical Devices; Gastroenterology-Urology Devices; Classification of the Ingestible Gastrointestinal Blood Detection Capsule
FDA classifies ingestible gastrointestinal blood detection capsule into class II with special controls.
US Federal Register - FDA Rules · United StatesMedical Devices; Immunology and Microbiology Devices; Classification of the Spinal Muscular Atrophy Newborn Screening Test System
FDA classifies Spinal Muscular Atrophy newborn screening test system as Class II with special controls.
US Federal Register - FDA Rules · United StatesMedical Devices; Anesthesiology Devices; Classification of the Real-Time Ultrasound Anatomy Visualization and Labeling Device for Ultrasound Guided Regional Anesthesia
FDA 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 StatesMedical Devices; Anesthesiology Devices; Classification of the Monitor for Opioid Induced Impairment of Oxygenation
FDA classifies monitor for opioid-induced impairment of oxygenation into Class II with special controls.
US Federal Register - FDA Rules · United StatesMedical Devices; General and Plastic Surgery Devices; Classification of the Skin Patch for Treatment of Hyperhidrosis
FDA classifies skin patch for hyperhidrosis treatment into class II with special controls.
US Federal Register - FDA Rules · United StatesMedical Devices; Orthopedic Devices; Classification of the Medial Knee Implanted Shock Absorber
FDA classifies medial knee implanted shock absorber as Class II with special controls.
US Federal Register - FDA Rules · United StatesMedical Devices; Neurological Devices; Classification of the External Lower Extremity Nerve Stimulator for Restless Legs Syndrome
FDA classifies external lower extremity nerve stimulator for Restless Legs Syndrome as Class II with special controls.
US Federal Register - FDA Rules · United StatesMedical Devices; General Hospital and Personal Use Devices; Classification of the Infant Supine Sleep System
FDA classifies the infant supine sleep system as Class II with special controls to ensure safety and effectiveness.
US Federal Register - FDA Rules · United States
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