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Biomedical Device Trial of Validation of Point of Care Liver Function Tests NCT NUMBER: PENDING NOVEMBER 28, 2018Version20181127 1 of 8 IRB APPROVAL FROM: 11/28/2018 TO: 04/23/2018UNIVERSITY OF PENNSYLVANIA RESEARCH
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Biomedical device trial is a regulated study that evaluates the safety and efficacy of a medical device before it is approved for public use.
Manufacturers or sponsors of medical devices are required to file a biomedical device trial.
Biomedical device trial forms can be filled out online or submitted via mail with all the required information regarding the study.
The purpose of a biomedical device trial is to ensure the safety and effectiveness of the medical device before it is marketed to the public.
The biomedical device trial must report information on study design, participants, interventions, outcomes, and adverse events.
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