journal of biomedical informatics
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Epidemiology and How It Is Used in Drug and Medical Device Litigation

Author(s): Reid Peter*

Any object designed for use in medicine is considered a medical device. Utilizing a device for medical purposes carries a large risk of risks; hence medical devices must be demonstrated to be safe and effective with a fair degree of assurance before governing governments permit the sale of the device in their nation. In general, the quantity of testing needed to verify a device's safety and efficacy increases as the associated risk does. Additionally, if related risk rises, the patient's potential benefit must rise as well. In Baluchistan, where Neolithic dentists utilised flint-tipped drills and bowstrings, researchers discovered what would be regarded as medical equipment by contemporary standards as early as 7000 BC. Research into Roman medical writings and archaeology also suggests that a variety of medical gadgets were in common usage during the time of ancient Rome. Medical devices weren't governed in the United States until the Federal Food, Drug, and Cosmetic Act (FD&C Act) was passed in 1938. The Medical Device Amendments to the FD&C Act, which were passed later in 1976, established medical device regulation and oversight in the United States as we know it today. The legislation that established the current system of medical device regulation in Europe was passed in 1993 and is collectively known as (MDD). The MDD was replaced by the Medical Device Regulation (MDR) on May 26, 2017

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