US Federal Register - FDA Rules is an official public source that HealthSignal monitors for Pharmaceuticals, Medical Devices. 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.
The Food and Drug Administration (FDA or we) is issuing a final rule to amend the standard of identity for pasteurized orange juice by lowering the minimum orange juice soluble solids content from 10.5[deg] to 10[deg]...
US Federal Register - FDA RulesThe Food and Drug Administration (FDA, the Agency, or we) is proposing to amend the drug establishment registration and drug listing requirements with respect to establishments engaged in distributed manufacturing and...
US Federal Register - FDA RulesThe 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 RulesThe Food and Drug Administration (FDA) is classifying the skin patch for treatment of hyperhidrosis into class II (special controls). The special controls that apply to the device type are identified in this order and...
US Federal Register - FDA RulesThe Food and Drug Administration (FDA) is classifying the monitor for opioid induced impairment of oxygenation into class II (special controls). The special controls that apply to the device type are identified in thi...
US Federal Register - FDA RulesThe Food and Drug Administration (FDA) is classifying the medial knee implanted shock absorber into class II (special controls). The special controls that apply to the device type are identified in this order and will...
US Federal Register - FDA RulesThe Food and Drug Administration (FDA, the Agency, or we) is proposing regulations to prescribe the format, content, and procedures for establishment registration and tobacco product listing. Complete and accurate est...
US Federal Register - FDA RulesThe Food and Drug Administration (FDA) is classifying the external lower extremity nerve stimulator for Restless Legs Syndrome into class II (special controls). The special controls that apply to the device type are i...
US Federal Register - FDA RulesThe Food and Drug Administration (FDA) is classifying the foam or gel chemical sterilant/high level disinfectant into class II (special controls). The special controls that apply to the device type are identified in t...
US Federal Register - FDA RulesThe Food and Drug Administration (FDA) is classifying the prognostic test for development or progression of preeclampsia into class II (special controls). The special controls that apply to the device type are identif...
US Federal Register - FDA RulesThe Food and Drug Administration (FDA) is classifying the SARS-CoV-2 serology test into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of ...
US Federal Register - FDA RulesThe Food and Drug Administration (FDA) is classifying the infant supine sleep system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part o...
US Federal Register - FDA RulesThe Food and Drug Administration (FDA) is classifying the breast implant suction retrieval system into class II (special controls). The special controls that apply to the device type are identified in this order and w...
US Federal Register - FDA RulesThe Food and Drug Administration (FDA) is classifying the computerized behavioral therapy device for the treatment of fibromyalgia symptoms into class II (special controls). The special controls that apply to the devi...
US Federal Register - FDA RulesThe Food and Drug Administration (FDA or we) is announcing that we have filed a food additive petition, submitted by Sterigenics U.S., LLC, proposing that we amend our food additive regulations to provide for the safe...
US Federal Register - FDA RulesThe Food and Drug Administration (FDA) is classifying the endoscopic light-projecting measuring device into class II (special controls). The special controls that apply to the device type are identified in this order ...
US Federal Register - FDA RulesThe Food and Drug Administration (FDA) is classifying the simple in vitro diagnostic device for the detection of secreted proteins from Bacillus species (spp.) in human clinical samples into class II (special controls...
US Federal Register - FDA RulesThe Food and Drug Administration (FDA) is classifying the endoscopic traction device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part o...
US Federal Register - FDA RulesThe Food and Drug Administration (FDA) is classifying the radiological machine learning-based quantitative imaging software with predetermined change control plan into class II (special controls). The special controls...
US Federal Register - FDA RulesThe Food and Drug Administration (FDA) is classifying the ingestible gastrointestinal blood detection capsule into class II (special controls). The special controls that apply to the device type are identified in this...
US Federal Register - FDA RulesThe 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 RulesThe Food and Drug Administration (FDA) is classifying the Spinal Muscular Atrophy newborn screening test system into class II (special controls). The special controls that apply to the device type are identified in th...
US Federal Register - FDA RulesThe Food and Drug Administration (FDA) is classifying the simple point-of-care device to directly detect SARS-CoV-2 viral targets from clinical specimens in near-patient settings into class II (special controls). The ...
US Federal Register - FDA RulesThe Food and Drug Administration (FDA) is classifying the combined acoustic and electrical external stimulation device for the relief of tinnitus into class II (special controls). The special controls that apply to th...
US Federal Register - FDA RulesThe Food and Drug Administration (FDA) is classifying the resorbable calcium salt bone void filler containing a single approved aminoglycoside antibacterial into class II (special controls). The special controls that ...
US Federal Register - FDA RulesThe Food and Drug Administration (FDA) is classifying the shoulder joint humeral (hemi-shoulder) ceramic head/metallic stem cemented or uncemented prosthesis into class II (special controls). The special controls that...
US Federal Register - FDA RulesThe Food and Drug Administration (FDA) is classifying the absorbable metallic bone fixation fastener into class II (special controls). The special controls that apply to the device type are identified in this order an...
US Federal Register - FDA RulesThe Food and Drug Administration (FDA or we) is amending the final rule that published in the Federal Register of April 16, 2026. That final rule updated regulations to reflect application-related actions for new anim...
US Federal Register - FDA RulesThe Food and Drug Administration (FDA) is classifying the rigid sterilization container with electronic monitoring into class II (special controls). The special controls that apply to the device type are identified in...
US Federal Register - FDA RulesThe Food and Drug Administration (FDA) is classifying the real-time ultrasound anatomy visualization and labeling device for ultrasound guided regional anesthesia into class II (special controls). The special controls...
US Federal Register - FDA RulesThe Food and Drug Administration (FDA) is classifying the adjunctive pain measurement device for anesthesiology into class II (special controls). The special controls that apply to the device type are identified in th...
US Federal Register - FDA Rules