Hi Fady: let’s, for a second, suppose that the auscultation, acoustic medical device, the stethoscope – known to be in use since 1816 – just got introduced to FDA for approval, what classification would anyone expect to be assigned the device; say, in comparison with the stent, of high invasivity during usage?

Measurements taken by both have to do with some aspect of heart functionality; that the heart is the sustainer of our lives, is nothing new to anyone.

You guessed it; most likely class 1 while the stent may be given a class 111 placement.

FDA categorizes medical into one of three classes: class 1, 11, or 111 based on their risks and the regulation controls necessary to provide reasonable assurance of safety and effectiveness. Class 1 devises generally pose the lowest risk to the patient and/or user whereas class 111 devises pose highest risks.

It might even make sense to say that the FDA’s concern is merely a matter of necessity – protect the public against hidden dangers.

Although a stethoscope has been in use since 1816, it has never been reported that anyone has been exposed to some level of danger through its use on them; the stent has.

The FDA’s medical device classification is only a precautionary measure set forth as an example for medical device designers and manufacturers to emulate.

However, were inspection of the harmless stethoscope brought in for the FDA’s approval be limited to verification and the designer of the devise insisted validation be conducted on the device as well, then that would be up to them. No one gets punished for such an act.