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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

Replacement-Hip-Joint-FDA-02You 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.

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