How are devices called that were on the market before FDA st

How are devices called that were on the market before FDA started regulating medical devices in 1976? Predicate devices Pre-amendment devices Pre-approved devices None of the above What elements are part of the usual process of establishing safety and effectiveness for a PMA device? Human testing Bench testing Animal testing All of the above

Solution

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Part 3: Choice b (Before the guidelines of FDA on 28th May 1976, the devices used to pateints were called as pre-amendment devices. A pre-amendment device is analysed by FDA for its safety, distribution and usability by patients by various means and at various levels of quarantine such as claims, technical, administrative and literature)

Part 4: Choice d (FDA checks all the products for their safety of utilization by pateints. This includes all, the laboratory testing or bench testing, tests conducted in vitro and in vivo using cellular and animal models along with any data from human clinical trial data. This ensures the safety of utilization of any device by the patients.)