FDA Considers Classification of ECT

Professor of Clincal Psychiatry; Director of the Brain Stimulation Division, Columbia University/New York State Psychiatric Institute

First published in Psychiatry Weekly, Volume 4, Issue 30, on December 21, 2009.

Introduction

With the increasing number of new brain stimulation techniques now available and on the horizon, does electroconvulsive therapy (ECT) still have a role? As a clinician and researcher, my reply is a definitive “yes.” Some recent and unexpected developments at the FDA concerning the classification of medical devices may, however, affect the availability of ECT to severely depressed patients.

History of ECT Classification

Codified in 1938, the FDA is nearly as old as ECT. The FDA was codified with the Federal Food, Drug, and Cosmetic Act during the same year that Cerletti and Bini introduced ECT in Italy (though Meduna introduced chemoconvulsive therapy two years prior). When the Medical Device Amendments were introduced in 1976, ECT devices were already on the market in the US. They are thus considered “pre-amendment” devices, meaning they did not go through the premarket approval application (PMA) route that devices introduced after 1976 are required to go through today.

The FDA has designated three levels of classification for medical devices, which relate to the level of safety and efficacy, and the controls that govern the uses of the device. This determination takes into account the intended use of the device and indications it is used for. Class I devices have the lowest risk, while Class III have the highest. The FDA classified ECT devices as Class III in 1979. According to federal regulations (21CFR860.3), “[A] device for which insufficient information exists to determine that general controls are sufficient to provide reasonable assurance of its safety and effectiveness” would be classified as Class III. For such preamendment Class III devices, the law directs the FDA to either reclassify the device to Class I or II, or require the device to remain as Class III and require submission of a PMA. Of the 149 preamendment Class III devices, all but 27 were either reclassified, or a PMA was required. ECT devices were among those 27 yet to be reclassified or subjected to a PMA requirement.

FDA Reclassification of ECT and Class III Devices

Three decades past the Medical Device Amendments, the FDA has made steps toward reclassification or requiring a PMA for the remaining preamendment Class III devices, including ECT. To this end, the FDA put a notice in the Federal Register in April 2009 requiring device manufactures to submit information concerning Class III, preamendment devices by August 7, 2009 in order to assist the FDA’s decision to either down-classify or call for PMAs. Specifically, they requested that manufacturers submit “any information known or otherwise available to them respecting such devices, including adverse safety or effectiveness information.”

The FDA has also asked the public to comment specifically on the matter of the ECT reclassification. Public comments are being solicited through a public docket published in the Federal Register and on the Internet. Members of the general public are invited to comment until January 8, 2010.

The Future of ECT

The future availability of ECT in the US depends on the outcome of these deliberations. It is foreseeable that this process is relevant to the clinical practice of ECT internationally; if ECT devices would no longer be available in the US at the same level, this would negatively affect evidence-based ECT use worldwide. ECT device manufacturers are small companies that may have difficulty mounting the resources needed to prepare a PMA or to conduct new large-scale clinical trials should those be required. Furthermore, the last seven decades have brought a wealth of evidence in the published medical literature concerning safety and efficacy of ECT that justify consideration of a down-classification to Class II, which would be a more accurate depiction of the evidence base regarding ECT.

Even if ECT is ultimately down-classified to Class II, there will still be a need to formulate the “Special Controls” that the FDA requires for Class II devices. Those controls will guide the way the device is regulated and ultimately used. According to the regulations, “Special Controls” include “performance standards, postmarket surveillance, patient registries, guidelines, recommendations, and other appropriate actions the agency deems necessary to provide such assurance.” It is still unknown what exactly those special controls might be. Professional organizations have already developed detailed standards for ECT, such as the American Psychiatric Association Task Force Report on ECT. This report includes detailed recommendations for informed consent, treatment, training, and privileging in ECT. This document may be an appropriate starting place for the formulation of “Special Controls” for the use of ECT.

Not surprisingly, these developments have not escaped the attention of the antipsychiatry movement. Indeed, their websites give explicit details about how to log on to the Federal Register, and the websites also provide suggested talking points. The comments are already pouring in.

Conclusion

All interested parties who are likely to be affected by these critical deliberations should have equal access to this information about this important development in our field. In addition to the medical community, patients, families, and patient advocacy groups are all stakeholders in these deliberations, and their voices deserve to be heard.

Disclosure: Dr. Lisanby chairs the APA Task Force on ECT and has received research support from Advanced Neuromodulation Systems/Saint Jude, Brainsway, Cyberonics, Fisher, Magstim, Magventures, and Neuronetics. She is co-inventor on a patent application filed by Columbia University for TMS technology.