Clinic Management Information Labelling 
IDStewardship
JUNE 19, 2025
Monthly visual loss screenings are essential to detect EON before significant changes occur, and patients should be informed about ocular toxicity symptoms. Although rare, preventing EON requires a baseline eye examination before starting ethambutol and stratifying at-risk patients. Disclosures: Nothing to disclose.
The FDA Law Blog
OCTOBER 10, 2022
Criterion 2 : Non-Device CDS software functions display, analyze or print medical information about a patient or other medical information. Here again, FDA’s novel interpretation of statutory terms effectively narrows the scope of information that a software product can display, analyze, or print and still be considered Non-Device CDS.
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ISPE
OCTOBER 27, 2022
DHTs may include mobile medical applications, health information technology, wearable devices, wireless sensors, telemedicine, electronic health records (EHRs), digital therapeutics, software as a medical device (SaMD), and artificial intelligence and machine learning (AI/ML) technology. Health information technology (IT).
ISPE
OCTOBER 27, 2022
DHTs may include mobile medical applications, health information technology, wearable devices, wireless sensors, telemedicine, electronic health records (EHRs), digital therapeutics, software as a medical device (SaMD), and artificial intelligence and machine learning (AI/ML) technology. Health information technology (IT).
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