The difference between cleared and approved

| Jun 7, 2019 | Medical Product Liability

There are actually two ways in which a manufacturer of a medical device, including infamous ones like certain types of hip implants and vaginal mesh, can get permission from the Food and Drug Administration to market it to the public.

One way is to submit the device to a formal approval process, in which case the device can be marketed as FDA Approved. What this means is that the device has gone through a time of great scrutiny and, presumably, a battery of tests that should verify that the device is safe for consumer in Northern Georgia and elsewhere.

However, the FDA will also allow the marketing of medical devices that are FDA Cleared. A Cleared device does not require such rigorous testing. In fact, all the manufacturer needs to prove to the FDA is that the device is substantially similar to other devices that are already on the market legally. The same level of testing is simply not required.

This distinction has been the subject of some criticism of late, including some spoofs by nationally known comedians. The truth behind the jest is that FDA Cleared is arguably a label without a real meaning. After all, between two similar medical devices, one can be designed and manufactured in such a way as to be safe while the other is flawed or even downright dangerous.

Consumers of medical devices should probably be a little wary of the FDA Cleared label. They should also remember that just because a medical device is being legally marketed, that fact does not make the device safe. If it turns out that the device is harmful to a patient, a patient can file a medical product liability case.