We have blogged and hosted numerous webinars on FDA regulation of mobile medical apps (see here, here, here, here and here); but if you are an app developer, you should be aware that FDA is not the only agency looking at your app. The Federal Trade Commission (FTC) may also be watching how you promote your app. In fact, on February 23, 2015 the FTC announced that it reached settlements with two firms marketing melanoma detection apps. The agency was unable to reach a settlement with a third developer and intends to pursue a judgment through litigation. Both apps claimed to provide an “automated analysis of moles and skin lesions for symptoms of melanoma and increase consumers’ chances of detecting melanoma in its early stages.” In sum, the FTC alleged in its complaints that the mobile app developers lacked adequate evidence to support such claims.
FTC authority coincides with other agencies in many respects, see e.g. here, and here. And there is nothing really new with the FTC taking action against mobile app developers. In 2011, the FTC filed complaints against developers of “acne cure” apps that claimed to treat acne through a light emitted from the device if you held it close to your face. The FTC alleged that those claims were unsubstantiated.
The FTC regulates many types of advertising and protects consumers by stopping unfair, deceptive or fraudulent practices in the marketplace. Under the Federal Food Drug and Cosmetic Act, the Food and Drug Administration (FDA) has regulatory authority over the labeling of all medical devices. Labeling includes any “written, printed, or graphic matter upon any article or any of its containers or wrappers, or accompanying such article…” Sections 502(q) and 502(r) of the FD&C Act authorize FDA to regulate the advertising of certain devices, which are known as restricted devices. Section 502(r) also states that restricted devices are not subject to FTC’s broad authority over advertising under 15 U.S.C. § 52-55.
Dr. Jeffery Shuren, Director of FDA’s Center for Devices and Radiological Health, summarized the FTC/FDA division of authority best: “FDA regulates the advertising of restricted medical devices while the FTC regulates the advertising of non-restricted devices.” A device becomes a “restricted device” when:
- FDA by regulation restricts a device to sale, distribution or use only upon the authorization of a practitioner licensed by law to administer or use such device, or upon other conditions that FDA prescribes in the regulation, if FDA determines that there cannot otherwise be reasonable assurance of the device’s safety and effectiveness. (Note that prescription devices may or may not be restricted devices).
- FDA requires, as a condition of approval of a Class III device, that its sale and distribution be restricted, but only to the extent that the sale and distribution of the device may be restricted by a regulation.
- FDA establishes, as part of a performance standard promulgated in accordance with section 514(b) of the FD&C Act, requirements that restrict the sale and distribution of a device, but only to the extent that the sale and distribution of the device may be restricted by a regulation.
Based on FTC’s description of the melanoma detection apps, it appears that the app developers are likely required to obtain premarket approval (PMA). FDA’s Mobile Medical Application Guidance provides that the Agency intends to actively regulate mobile apps that “use the mobile platform’s built in features, such as… a camera, to perform medical device functions.” The melanoma apps use the device platform (i.e. the camera) to collect and review an image for use in providing a diagnosis. Furthermore, this type of app appears to perform the same medical device functions of an “optical diagnostic device for melanoma detection” which FDA classifies as Class III under product code OYD, which requires a PMA. In addition, FDA premarket approval letters indicate that “optical diagnostic devices for melanoma detection” are restricted devices pursuant to 21 C.F.R. § 801.109.
It appears that FDA would, upon premarket approval, treat these types of melanoma apps as restricted devices and therefore would have authority to regulate the app’s advertising. However, it remains that these app developers never submitted a premarket application or received premarket approval from FDA. Therefore, the Agency was not able to require, as a condition of approval, that their sale and distribution be restricted. As such, FDA does not have the ability to regulate the advertising of these apps.
The instant FTC complaints and settlements appear relatively minor compared the potential FDA issues involving marketing a product without approval. More importantly, FDA is in no way foreclosed from taking action so we will see if and when FDA acts in the coming months against the app developers.