GAITHERSBURG, Md. -- The FDA should continue to regulate electroconvulsive therapy (ECT) machines as high-risk devices for treating depression and most other conditions for which ECT is typically used, members of the agency's Neurological Devices Advisory Committee agreed.
No formal vote was taken, but a majority of members supported keeping ECT devices for most indications as Class III -- the highest-risk category -- in the FDA's regulatory structure for medical devices, an FDA spokeswoman said.
There was one exception, she said. Panel members were divided on whether ECT devices could be reclassified into the moderate-risk Class II for treating catatonia or whether they should stay in Class III for that indication.
ECT devices are already considered Class III, but the FDA has never developed standards for approving new machines with the premarket approval (PMA) process that is supposed to be used for high-risk products. Instead, the agency has cleared new models under the 510(k) process that merely requires manufacturers to demonstrate that the products are "substantially equivalent" to devices already on the market.
In 2009, the Government Accountability Office (GAO) recommended that the 510(k) process not be available for Class III devices. Such devices, the GAO said, should either be reclassified into the less-risky Class II category or else their manufacturers should have to go through the PMA process, which typically requires clinical safety and efficacy testing.
Consequently, the FDA was seeking guidance from its neurological devices advisory panel on whether ECT equipment deserved a lower-risk classification. Earlier in the week, the agency posed a similar question to its cardiology devices committee regarding automated external defibrillators. (Answer: no.)
ECT has been shown to be highly effective for treating acute, severe unipolar and bipolar depression and is also approved for schizophrenia, bipolar mania, schizoaffective and schizophreniform disorders, and catatonia.
On the other hand, the treatment has been controversial almost since it was first introduced in the 1930s. Patients complained of persistent adverse effects such as memory loss and cognitive dysfunction. Although protocols have changed dramatically since then, and adverse event rates in systematic analyses have plummeted, the complaints have not gone away completely.
Advocacy groups opposed to ECT urged the FDA not to reclassify the devices out of Class III. A briefing document prepared by FDA staff included a long list of known risks associated with ECT, ranging from skin burns and oral fractures to stroke and death.
The agency is not required to follow the advice of its advisory committees, but it usually does.
One middle-ground option available to the FDA is to reclassify the devices as Class II, but require so-called special controls, such as restrictions on which physicians may apply ECT, or more detailed instructions on how the devices should be used.