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cdj24 replied to the topic A advertising a sum of its parts? in the forum Introduction to Project Management 7 years, 4 months ago
I agree and think that there should be more regulation on what patients are being told. If the company is not the one suggesting high intensity and extreme sports be performed then the claims of the company are not the issue and it may not fall under the FDA. If the company has gone through approval on the claims they are marketing with, then secondary approval is not needed. The lifespan of a joint replacement might be much shorter when the recommended use is not followed by the patient or like you said shop around for a doctor who goes against what the company says their device can do and should be used for. If studies are done by companies for their device to be used during extreme sports when that is not what their original claim stated, I think then they would need to go through the FDA and be approved for that.