Last week, the U.S. Food and Drug Administration (FDA) finally decided to start taking action to close a loophole that’s been around nearly as long as the agency itself. Last Wednesday it said that it would require safety and efficacy data from manufacturers of medical devices in 25 different categories. This data is equivalent to the types of data the FDA currently requires for medical devices and drugs — data that shows the device is both safe and effective in use for a prescribed disorder.
One of those 25 categories is electroconvulsive therapy (ECT) machines. Yes, you heard right. For decades, the most notorious of all psychiatric treatments available has never met any type of rigorous FDA approval for their use. How can this be?
In the case of electroconvulsive therapy machines, for example, there are eight companies that market the devices, none of which were ever required to undergo premarket approval.
Rather, they all were cleared under the so-called 510(k) process, which automatically okays the devices if it is "substantially equivalent" to an already approved product, called a predicate device.
Since no ECT machine went through the premarket approval process, there is no predicate device. Hence, manufacturers of ECT machines must seek approval for them as if they were new to the market.
The good news is that the FDA is finally fixing this loophole. The bad news (or more good news, depending upon how you look at it) is that the resulting need for rigorous data may mean that ECT machines may be a thing of the past. While ECT machines make a few companies some money, the kind of clinical trials the FDA may require may mean it is economically unadvisable to fund the studies.
Time will tell how the machines’ makers will react to this requirement, but I think this has been too long a time in coming. It’s necessary to make sure everyone who offers legitimate medical devices or drugs for things like depression are on the same level playing field. And it ensures that consumers are not subjected to unsafe devices, as the memory side effects of ECT treatment remain a hurdle to its more widespread use or adoption, even when modern ECT techniques are used.
Serious depression may occasionally need serious treatment like ECT. But such treatments must meet the same requirements the FDA places on all medical devices. Finally, ECT will be required to submit proof of showing they meet minimum levels of safety and efficacy.
Read the full article: FDA Near to Closing Books on Grandfathered Medical Devices