US Federal Register - FDA Rules is an official public source that HealthSignal monitors for Pharmaceuticals, Medical Devices & IVD. The most recent updates we have tracked from it are listed below, each normalised into our index and linked back to the original publication on the source's own website.
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 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 StatesFDA 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 StatesFDA issues final guidance on biological hazard controls for ready-to-eat fresh-cut produce manufacturers, superseding 2008 guidance.
US Federal Register - FDA Rules · United StatesNewFDA 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 prognostic test for chronic kidney disease progression assessment into 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 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 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 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 StatesThe Food and Drug Administration (FDA, the Agency, or we) is amending its regulations to direct the public to organizational and contact information available on the Agency's website. FDA is also revoking certain regu...
US Federal Register - FDA Rules · United StatesFDA proposes to amend drug establishment registration and listing rules to enable distributed manufacturing facilities to register as single establishments and align foreign establishment requirements with the PREVENT Pandemics Act.
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 SARS-CoV-2 serology test as Class II device 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 absorbable metallic bone fixation fasteners 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 resorbable calcium salt bone void filler with aminoglycoside antibacterial 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 StatesFDA classifies the breast implant suction retrieval system as Class II with special controls.
US Federal Register - FDA Rules · United StatesFDA classifies rigid sterilization containers with electronic monitoring as Class II devices subject to special controls.
US Federal Register - FDA Rules · United StatesFDA proposes to extend establishment registration and tobacco product listing requirements to foreign owners and operators, currently exempt.
US Federal Register - FDA Rules · United StatesFDA classifies foam or gel chemical sterilant/high level disinfectant devices into class II with special controls.
US Federal Register - FDA Rules · United StatesFDA revokes the authorized use of Orange B color additive for frankfurter and sausage casings or surfaces, determining the use has been abandoned.
US Federal Register - FDA Rules · United StatesFDA amends pasteurized orange juice standard of identity, lowering minimum soluble solids from 10.5° to 10° Brix and permitting up to 15% Citrus reticulata juice.
US Federal Register - FDA Rules · United StatesFDA proposes to repeal the color additive regulation for Citrus Red No. 2 on orange skins, unused since 2020.
US Federal Register - FDA Rules · United StatesFDA corrects inadvertent errors in instructions for technical amendments to new animal drug application regulations.
US Federal Register - FDA Rules · United StatesFDA denies Micro-Tracers' objections to the repeal of FD&C Red No. 3 color additive regulations and lifts the administrative stay on the effective date.
US Federal Register - FDA Rules · United StatesFDA announces receipt of a food additive petition from Evonik Corporation proposing approval of ethyl cellulose as a binder and coating for amino acids in ruminant animal feed.
US Federal Register - FDA Rules · United StatesFDA announces receipt of a food additive petition proposing ionizing radiation for pathogen reduction in raw enriched wheat flour.
US Federal Register - FDA Rules · United StatesThe Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), ...
US Federal Register - FDA Rules · United States