Journals on Medical Drug and Therapeutics - BJSTR Journal

Abstract

The new FDA class 3 automatic medical devices regulations were recently introduced to meet criticism of all sides on the past regulations. An evolving Essure scandal accelerated the launching of this ambitious new plan. Unfortunately, the last FDA approvals, a #transcranial magnetic deep brain stimulation system (TMS) and a vaginal hormonal contraceptive ring, don't reflect this new wave. Recently, The Brainsway Deep Transcranial #Magnetic Stimulation System received FDA marketing clearance for the treatment of #obsessive compulsive disorder [OCD]-[1]. OCD is commonly treated with medication and/or psychotherapy but some patients continue to experience symptoms. Transcranial magnetic stimulation [TMS] uses magnetic fields to stimulate nerve cells in the brain. The FDA previously permitted marketing of TMS to treat major depressive disorder in 2008 and for pain associated with certain migraine headaches in 2013 [2,3]. The Brainsway device was reviewed under the FDA de novo premarket review pathway intended for some low- to moderate risk devices that are novel and for which there is no legally marketed predicate device to which the device can claim substantial equivalence [4]. Another recently approved device under this new automatic class 3 designation is a #self-administered contraceptive vaginal system approved for up to 1 year of use [5]. There has been a lot of criticism on the FDA's medical device oversight facing criticism from all sides.

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FDA Approvals of Medical Devices Under the De Novo Automatic Class 3 Regulations: An Opinion by Michael AB Naafs in BJSTR