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Source article for full text: How does the FDA ‘approve’ medical products? – Medical News Today.
How does the FDA ‘approve’ medical products?
Thursday 20 February 2014 – 8am PST
You may have seen medical products that claim to be “FDA cleared,” “FDA registered,” “FDA listed” or “FDA approved” – but what do these labels mean? You would be forgiven for feeling confused.
In this feature, we look at what the differences in Food and Drug Administration (FDA) classification actually mean, what you need to be aware of as a consumer and what the future holds for the regulation and classification of medical products in the US.
Though you may see labels on a wide variety of medical products – from implantable defibrillators to smartphone apps – bearing legends such as “FDA registered,” in reality these claims are often disingenuous. But regulation over the correct terminology is rarely enforced.
Yet, ironically, my 2 Smith & Nephew Resurfacings that failed, got me dropped from a case because the implements had received a stricter FDA examination. ALL Smith & Nephew hip implements have failed. 4 hip replacements since 2007, but excluded because I didn’t have the right kind of failed implement. And then there’s preemption. And the statute of limitations was Dec. 1, 2013. It’s been more than 2 years and they are not yet healed. This kind of life is not for sissies (which I am, so I don’t manage it well), but o I would love to wake up without pain! Not easy to eat crow on this one.
Smith & Nephew are corporate criminals exploiting a technology known to damage, hiding behind law that was never meant to protect them – it was meant to protect patients but it doesn’t. So sad.
Thanks for your empathy, and, as always, your thorough scholarship.
mickey morgan aka mickeypamo