Dive Brief:

• FDA has published a final order reclassifying electroconvulsive therapy (ECT) devices as Class II products in some circumstances.

• After assessing feedback to its plan to move the devices into a lower risk category, FDA has expanded the patient population in which ECT products are deemed to be Class II therapies.

• The final order, which goes into effect on Dec. 26, furthers FDA’s reclassification of the more than 170 devices grouped in Class III during the early days of its medtech regulations.

Dive Insight:

FDA has spent the past 40 years revising the regulatory status of the 170-plus types of devices it put in Class III on a temporary basis. Manufacturers of the devices granted that status in the late 1970s were allowed to continue selling their products without filing for premarket approval (PMA). Over time, FDA planned to either reclassify the devices or keep them in Class III and call for PMAs.

Having made a concerted effort to process the devices over the past decade, FDA had got the list of outstanding products down to two. The final order for ECT devices will leave the agency with just one more type of product still to reclassify.

FDA proposed reclassifying ECT devices, which send electrical current through the brain, three years ago. Over the following three months, the agency received more than 3,400 comments on its proposals. Not everyone was in favor of treating ECT devices as moderate-risk products, but many others were and in some cases argued that FDA was being too conservative in its reclassification.

FDA originally proposed to classify ECT devices as Class II products when they are used to treat a severe major depressive episode (MDE) associated with major depressive disorder or bipolar disorder, provided the patient is over 18 years of age and either treatment-resistant or in need of rapid care due to the severity of their condition. All other uses of ECT would remain in Class III.

However, some commenters argued the data support categorizing ECT devices as moderate risk in a wider range of situations. FDA was not convinced by many of these arguments but, having reviewed the data, has accepted that its original classification was too narrow.

As such, FDA is adding catatonia, a condition defined by unresponsiveness to external stimuli, to the list of indications in which ECT devices are treated as Class II products. In addition, FDA is lowering the minimum age in which ECT devices are Class II products to 13 years, in both catatonia and MDE.

FDA’s rethink will spare manufacturers of ECT devices, such as Mecta, from the need to file a PMA if their products are used to treat certain patients with catatonia or MDE. However, FDA wants manufacturers to submit PMAs if they plan to continue using their devices in the treatment of any condition not covered by the reclassification, such as schizophrenia.

Some commenters pushed back against FDA’s proposed PMA requirement, arguing that it is “disingenuous because PMA applications have not been required for ECT devices since they were originally classified,” according to the agency. FDA dismissed those arguments, though, and has given manufacturers 90 days to submit PMAs.