FDA Accreditation Terminology – Magic or Misdirection?
Have you ever watched a really good magician? It is incredible the tricks they can create before your very eyes and you are left amazed with the performance. When it comes to reviewing technology in the medical industry, you also have to be certain that companies are not playing tricks on you with the wording they use to describe their capability. Recently, the FDA announced long awaited social media guidance for medical marketing. The good news is the FDA is taking notice with this misdirection. The not so great news is the guidance covers drugs and biologics and does not yet apply to medical devices (which includes software).
Any medical practitioner would tell you that they would not even consider using a tool that was not accredited by the FDA. This seems like common sense but there is a critical issue brewing that every medical institution must be aware of – companies using misleading statements when it comes to their FDA accreditations, or lack of accreditations. What tools are really adequate when it comes to making a primary diagnosis, especially using mobile devices?
First, it is important to differentiate clearly between classification, intended use and FDA clearance for medical devices and software. For example, a 2D-only image viewer with limited functionality may qualify as a Class I “Image Communications Device”, not requiring any review for safety and effectiveness by the FDA and therefore is not accredited for primary diagnostic use since no FDA review is required. It is strictly for image review only.
Conversely, a medical image viewer with robust functionality including 2D, MIP/MPR, 3D and other image reconstruction and manipulation tools is classified as a Class II medical device under the PACS regulation. It must be reviewed for safety and effectiveness and cleared by the FDA before it can be sold. If the manufacturer specifies that a medical image viewer is intended for primary diagnosis, the Class II FDA clearance allows a physician to make the initial read and primary diagnosis of that patient’s condition from the software.
The mud gets a little thicker when the viewer is running on a mobile device. In this case, the FDA is much more interested in the effect that the mobile device display has on image quality and suitability for primary diagnostic use. Manufacturers who specify primary diagnostic use for a mobile viewer are subject to rigorous FDA review including technical validation of the mobile device running their app.
One would think that Class I vs. Class II, no FDA review vs. rigorous FDA review, non-diagnostic use vs. clearance for primary diagnostic use, is a pretty clear distinction, particularly in the U.S. market which is one of the most litigious in the world. What physician would want to dare to do a primary diagnosis on a patient using a non-accredited piece of technology when their career is at stake in the event of a wrongful diagnosis and subsequent treatment using that technology? The fact is half of radiologists may be sued by the time they are 60. Why would anyone want to further increase that risk?
Unfortunately, it is very difficult to distinguish between the misleading language that is being used in the industry. We see a few examples that are common. First, stating that a product is FDA accredited or approved when it is merely listed in the FDA database as a device sold by a particular manufacturer. That is a statement that is true, but it is also incomplete. Just because it is classified as Class I and its intended use is for image review, does not mean that you can or should use the product for primary diagnosis. Another simple method is to just clearly label a web product as FDA accredited, in the event it is, and let the buyer assume that the mobile product under the same label is as well, even if it is not. This is misdirection by simply choosing to not highlight all the facts.
This is a very serious issue in the global healthcare software market; it is both a patient safety issue, as well as a huge liability issue for the institution and its physicians.
As a healthcare buyer of technology or a medical practitioner, make sure to ask the right questions when reviewing medical imaging technology.
See Calgary Scientific if you want to get the guide and access all the key aspects you should be taking into account.