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The Food and Drug Administration issued a final order Dec. 21 reclassifying electroconvulsive therapy (ECT) devices from class III, indicating higher risk, to class II, indicating moderate risk, in certain cases.
Conditions included in the new order are catatonia or a severe major depressive episode associated with major depressive disorder or bipolar disorder in patients over the age of 13 years who are resistant to treatment or who require a rapid response because of the severity of their psychiatric or medical condition, according to an FDA press release.
In addition, the final order requires the filing of premarket approval application for class III devices used for all conditions not reclassified as class II.
“The FDA is issuing this final order to regulate ECT devices in a way that appropriately reflects the known benefits and risks of these devices for their indications for use, provides patients with additional protections, and gives physicians more information on the safe and effective use of these devices,” the agency said in the press release.
The Food and Drug Administration issued a final order Dec. 21 reclassifying electroconvulsive therapy (ECT) devices from class III, indicating higher risk, to class II, indicating moderate risk, in certain cases.
Conditions included in the new order are catatonia or a severe major depressive episode associated with major depressive disorder or bipolar disorder in patients over the age of 13 years who are resistant to treatment or who require a rapid response because of the severity of their psychiatric or medical condition, according to an FDA press release.
In addition, the final order requires the filing of premarket approval application for class III devices used for all conditions not reclassified as class II.
“The FDA is issuing this final order to regulate ECT devices in a way that appropriately reflects the known benefits and risks of these devices for their indications for use, provides patients with additional protections, and gives physicians more information on the safe and effective use of these devices,” the agency said in the press release.
The Food and Drug Administration issued a final order Dec. 21 reclassifying electroconvulsive therapy (ECT) devices from class III, indicating higher risk, to class II, indicating moderate risk, in certain cases.
Conditions included in the new order are catatonia or a severe major depressive episode associated with major depressive disorder or bipolar disorder in patients over the age of 13 years who are resistant to treatment or who require a rapid response because of the severity of their psychiatric or medical condition, according to an FDA press release.
In addition, the final order requires the filing of premarket approval application for class III devices used for all conditions not reclassified as class II.
“The FDA is issuing this final order to regulate ECT devices in a way that appropriately reflects the known benefits and risks of these devices for their indications for use, provides patients with additional protections, and gives physicians more information on the safe and effective use of these devices,” the agency said in the press release.