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Buried reports hide details of medical device failures

According to the Medicare Payment Advisory Commission, the medical device industry has developed and sold an enormous number of products they feel play a crucial role improving the ability to diagnose and treat illness. However, there are a relatively small number of large diversified companies supplying these devices specific for therapeutic use.  In a report to Congress, the Medicare Payment Advisory Commission stated: “The industry is distinctive both for its tendencies to make frequent, incremental changes to its products and its extensive ties with physicians.”  While medical devices are regulated by the Food and Drug Administration (FDA), the regulatory framework is less stringent than that used for pharmaceutical drugs. Many devices considered to be low risk may be marketed without prior approval and those considered medium risk are only required to demonstrate they are substantially equivalent to an existing device before being marketed.  Read more....

 

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