Jan 31, 2011

The US Food and Drug Administration’s Neurological Devices Advisory Committee came out last week in support of further testing of devices used in electroconvulsive therapy (ECT). ECT devices used in perennially controversial “shock therapy” would retain their Class III status based on the 18-member committee’s recommendations, but also submit to expensive and data-intensive premarket approvals (PMAs); such products had heretofore not had to undergo PMA submissions, and new ECT products have been cleared via the FDA 510(k) process, according to MedPage Today and The Washington Post. Prompted by the Government Accountability Office (GAO) in 2009 to address Class III high-risk devices being cleared through the less stringent 510(k) process, the FDA is now considering whether to move ECT products into the Class II category—a move favored obviously by ECT device manufacturers as well as some mental health professionals advocating ECT as a viable option for disorders such as severe depression—or keep them categorized as Class III and require PMAs for both existing and new products. If the latter approach is taken, as it probably will, ECT device manufacturers will have to provide clinical evidence demonstrating their wares’ safety and efficacy, potentially via new clinical studies. The FDA recently deliberated similar issues with automatic external defibrillator devices, and appears poised to begin requiring more in-depth testing of those products, as well, indicating that the regulator is making good on the Class III-related recommendations it received from the GAO in 2009.


  • Stewart Eisenhart