FDA Approvals of Medical Devices Under the De Novo Automatic Class 3 Regulations: An Opinion

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FDA Approvals of Medical Devices Under the De Novo Automatic Class 3 Regulations: An Opinion

Journal Title: Biomedical Journal of Scientific & Technical Research (BJSTR) - Year 2018, Vol 8, Issue 2

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. Some have accused the agency of approving devices on the basis of weak evidence and surrogate endpoints, with cardiovascular devices making up the largest class of recent FDA recalls. Others have complained that delays to device approvals are putting patients at risk and deterring innovation [6]. FDA has announced the de novo class 3 regulation as a new "action plan" to address concerns throughout the life cycle of medical devices from premarket review through postmarket surveillance, with emphasis on the growing importance of cybersecurity. In a statement issued April 17, FDA Commissioner Scott Gotlieb, MD, announced the release of the Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health [7]. A past medical device approval leading in part to the new regulations is known as the Essure debacle [8]. Essure is a device consisting of two flexible metal coils inserted into the Fallopian tubes that are supposed to cause enough scarring to stop sperm from passing through to fertilize eggs. This device entered the market 16 years ago by Bayer. Since then, over 15.000 patients have filed lawsuits against Bayer and thousands of women have reported complications to the FDA including Fallopian tube perforations, unintended pregnancies, autoimmune symptoms and severe pain and bleeding that have resulted in hysterectomies [8].

Authors and Affiliations

Michael AB Naafs

Keywords

EP ID EP590534
DOI 10.26717/BJSTR.2018.08.001623
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