How does the FDA 'approve' medical products?

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.

Class 1, 2 and 3

In truth, the only products that the FDA specifically "approve" are drugs and life-threatening or life-sustaining "Class 3" medical technology (such as defibrillators). These are submitted to a rigorous review process called "pre-market approval" (PMA), to prove that the benefits of the products outweigh any potential risks to the health of the patient.