By Rajnish Mago, MD (bio)
Whether we like it or not, FDA “approval” of any treatment has a big impact on how likely it is to be used. That is why advertisements for medical devices often refer to endorsement by the FDA. An example of this is shown in the image below.
Referring to clearance or approval by the FDA reassures patients, their loved ones, and the clinicians treating them.
But, clinicians and others often refer to certain interventions as “FDA-approved” when they only “FDA-cleared”. Continuing with the example of the Alpha-Stim® Cranial Electrotherapy Stimulator device, I have heard clinicians say that it has to been “proven to work” and is “FDA-approved”. Note that the ad for the Alpha-Stim CES device shown above did not say that it is FDA “approved”; it said that it is FDA “cleared”. The manufacturer’s website (LINK) also acknowledges
The screenshots below, which are from the websites of two of the manufacturers of TMS devices in the US (the red ovals were added by us) show that even TMS devices are referred to as being “FDA cleared” rather than that they are “FDA approved”.
What’s the difference between FDA approval and FDA clearance? And does it make any real difference? My point is not at all to detract from the efficacy of any device. For example, I often refer my own patients for TMS. But, we should know that most medical devices—in mental health and in other fields of medicine—are FDA cleared and not FDA approved.
One Editorial (Ravich, 2008) noted:
It is important that practicing clinicians understand the meaning and limitations of the terms ‘‘FDA approval’’ and ‘‘FDA clearance’’ for medical devices and recognize that ‘‘FDA clearance’’ is often granted with minimal documentation of efficacy.
The Editorial also bemoaned…
… a general ignorance among practicing physicians about the nature of the FDA’s decision processes regarding medical devices.”
A house divided…
Let me explain the difference between FDA approval and FDA clearance briefly. To do this, we have to understand that the FDA approaches drugs and medical devices very differently. These two types of interventions are evaluated by different arms of the FDA. Drugs are evaluated and regulated by the FDA’s Center for Drug Evaluation and Research (CDER) and medical devices are evaluated and regulated by its Center for Devices and Radiologic Health (CDRH).
The FDA has a class system for devices
In 1976, regulations regarding medical devices were added to the Food, Drugs, and Cosmetics Act. Devices already on the market prior to 1976 were exempt from these new regulations. Medical devices introduced after 1976 are considered by the FDA to belong to one of three classes—Class I, Class II, or Class III, in increasing order of potential risks and also depending on known similarity to devices already on the market, which the FDA refers to as “predicate” devices.
For Class II devices, like the TMS devices, the FDA’s Center for Devices and Radiologic Health (CDRH) conducts a process called “Premarket Notification” or the 510(k) process and gives “clearance” for the device to be marketed. The evaluation of the device is based on the manufacturer being able to show that the new device is “substantially equivalent” to another similar device that is already being marketed. Class II devices don’t require that extensive pre-clinical or clinical data be submitted to the FDA (Norman, 2016).
Class III devices are those that involve new technology or
Lastly, let’s see where devices of interest to mental health clinicians fall in this classification system and whether they are FDA approved under the Premarket Approval process or only FDA cleared under the 510 (k) process. To understand this, we have to understand how devices can be reclassified from one class to another.
Reclassification from Class III
Any device introduced after 1976 is at first automatically classified as a Class III device. The manufacturer can then petition the FDA under Section 513 (f) (2) of the Food, Drugs, and Cosmetics Act for the device to be reclassified as Class I or Class II and ask for it to be cleared through the (less rigorous) 510(k) process. This reclassification can be based on showing that the device either carries only low/moderate risk and/or it is substantially equivalent to an already marketed (“predicate”) device.
This is exactly how the first TMS device, the NeuroStar Transcranial Magnetic Stimulation (TMS) System manufactured by Neuronetics, was cleared by the FDA—not “approved”—in 2008 after being reclassified as a Class II medical device. The reclassification letter can be seen HERE and the 510 (k) clearance letter can be seen HERE.
Similarly, in 2018, the FDA agreed to reclassify the Brainsway Deep TMS System for adjunctive treatment of adults with obsessive-compulsive disorder to Class II, which allowed it to be cleared by the FDA using the premarket notification or 510 (k) process; the FDA’s letter is available HERE.
Brainsway is wrong in claiming on its website that its device received FDA approval.
The Alpha-Stim® Cranial Electrotherapy Stimulator device is also not “FDA approved”; it was FDA-cleared under the 510 (k) process by being reclassified as a Class II device (LINK).
Jarow JP, Baxley JH. Medical devices: US medical device regulation. Urol Oncol. 2015 Mar;33(3):128-32. doi: 10.1016/j.urolonc.2014.10.004. Epub 2014 Nov 6. Review. PubMed PMID: 25458071.
Ravich WJ. Endoluminal reflux therapy: what do “FDA clearance” and “FDA approval” mean? Gastrointest Endosc. 2008 Nov;68(5):845-8. doi: 10.1016/j.gie.2008.04.012. PubMed PMID: 18984098.
Copyright 2019, Rajnish Mago, MD. All rights reserved. May not be reproduced in any form without express written permission.
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