Devices remain unclassified

I read a really interesting article this week written by Josh Rising called "The Loophole That Keeps Precarious Medical Devices in Use". The articles explains how when the Medical Device Amendments of 1976 were implemented, dozens of marketed medical devices were left unclassified. The 1976 Amendments immediately took actions on newly developed devices and classified devices already on the market as "medium-risk" devices until the FDA could take the time to evaluate the real risk of those devices on an individual basis.

Seems reasonable right? Enforcing law immediately on new products while retroactively analyzing the classification of already marketed devices. This seems like a good solution for marketed devices that were of lower risk. However what about the devices that are of high risk, higher than "medium-risk"?

An example of this which has come into the spotlight over the last years are artificial hips. There have been many cases of device failure which have resulted in harm to the patient and also required surgical action. Had this device been classified as high risk from the beginning many of the problems seen with artificial hips in the field might not have happened.

According to the article, there are currently still 19 devices that are unclassified. How many of these devices are of high risk?

--Jillian F. Walker