Chutzpah. The Yiddish word “chutzpah” is one of those words with a meaning that is best defined anecdotally, as it applies to audacity, but audacity of a very specific kind and it can be easily applied to medical device companies. Allies of the medical device industry waged an extraordinary campaign in Washington to discredit a report by one of the country’s pre-eminent scientific groups that examines possible new regulations on the industry. The report, by a panel at the Institute of Medicine said the government’s system for regulating many medical devices should be abandoned and replaced because it fails to examine their safety and effectiveness before sale. A new study by the Times on hip replacements only proves they are right and that the FDA needs to take a harder look at medical device approvals.
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