Annals of internal medicine
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Nearly all medical devices reviewed by the U. S. Food and Drug Administration (FDA) are authorized via the 510(k) clearance process. ⋯ Advocates of the 510(k) clearance process tout its support for device innovation and rapid market access, and critics of the 510(k) clearance process express that it may inadequately protect patient safety. In September 2023, the FDA issued 3 guidance documents that, if finalized, would significantly change medical device regulation. This article provides clinical and regulatory context for the proposed guidance documents, which focus on predicate selection, clinical testing requirements, and implantable devices, and identifies opportunities for further reforms that promote transparency and patient safety.
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Randomized Controlled Trial Multicenter Study
Diabetes Risk Factors in People With HIV Receiving Pitavastatin Versus Placebo for Cardiovascular Disease Prevention : A Randomized Trial.
REPRIEVE (Randomized Trial to Prevent Vascular Events in HIV) led to new guidelines for statin use among people with HIV (PWH) with low to moderate risk for atherosclerotic cardiovascular disease (ASCVD). Little is known about the natural history of diabetes mellitus (DM) or mechanisms contributing to statin effects on DM among this population. ⋯ National Heart, Lung, and Blood Institute of the National Institutes of Health.
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Randomized Controlled Trial Multicenter Study
Effectiveness of Integrating Suicide Care in Primary Care : Secondary Analysis of a Stepped-Wedge, Cluster Randomized Implementation Trial.
Primary care encounters are common among patients at risk for suicide. ⋯ National Institute of Mental Health.
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Randomized Controlled Trial Multicenter Study
Effect of Four Hemoglobin Transfusion Threshold Strategies in Patients With Acute Myocardial Infarction and Anemia : A Target Trial Emulation Using MINT Trial Data.
The optimal hemoglobin threshold to guide red blood cell (RBC) transfusion for patients with acute myocardial infarction (MI) and anemia is uncertain. ⋯ National Heart, Lung, and Blood Institute.
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There are considerable challenges when using difference-in-differences (DiD) analysis of ecological data to estimate the effectiveness of public health interventions in rapidly changing situations. ⋯ None.