FDA panel advice may require trials to prove safety of ECTBMJ 2011; 342 doi: https://doi.org/10.1136/bmj.d661 (Published 31 January 2011) Cite this as: BMJ 2011;342:d661
- Janice Hopkins Tanne
- 1New York
A committee of the US Food and Drug Administration has recommended that devices used to deliver electroconvulsive therapy (ECT) should remain classified as class III devices, the highest risk category.
The ruling may require the two companies that make the devices in the United States to conduct trials to demonstrate the safety and effectiveness of the devices for the first time. The companies say that the cost of such studies may be prohibitive.
The recommendation from the FDA’s neurological devices advisory committee was made on …