In late May, the U.S. Food and Drug Administration took regulatory action against a mobile medical application or "mHealth" app for the first time. In its "It Has Come to Our Attention" letter to Biosense Technologies Private Limited, FDA contended that the company's new urine analysis app required FDA pre-clearance prior to marketing. The uChek Urine Analyzer uses a smartphone's camera to digitally analyze urinalysis dipsticks already sold by several other companies. FDA noted that these dipsticks had been approved for "direct visual reading" and interpretation, but not for the automated analysis performed by the uChek app. Accordingly, the entire dipstick-mobile app system needed a separate clearance, along the lines of a similar device already approved by FDA and referenced in the letter.
Previously, only the Federal Trade Commission had taken enforcement action against an mHealth application. In 2011, the FTC prohibited the marketing of two mobile phone applications that claimed to cure acne through the use of colored lights emitted by the phones.
Although FDA has given comparatively less attention to mHealth apps, the agency did issue its Draft Guidance on Mobile Medical Applications in July 2011. In that guidance, the FDA stated that it would only regulate those mHealth apps—FDA uses the term "mobile medical applications" or "MMA"—that both: (1) met the definition of a "device" under Section 201(h) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. § 321(h)]; and (2) were "used as an accessory to a regulated medical device" or "transform a mobile platform into a regulated medical device."1
If the mobile medical application was a medical device because it was an accessory to a regulated medical device, then the MMA "takes on" the same classification as the device to which it is an accessory and will have to satisfy the same regulatory requirements as its "parent" device. Depending on the parent device's classification, this could mean that the MMA developer will need to submit a 510(k) Pre-Market Notification to FDA or even a Premarket Approval Application (PMA) if the parent device is a Class III device for which a PMA is required.2
While FDA has not yet finalized its guidance on which mHealth apps it intends to regulate, the warning letter suggests that the agency has begun to examine mHealth apps more closely. Going forward, mHealth app developers should carefully assess whether their apps are considered mobile medical applications subject to immediate regulation under the 2011 draft guidance. Developers also should review similar apps or products that have already received 510(k) clearance from the FDA. Based on the warning letter, the approval/clearance of comparable mHealth apps or product as medical devices greatly increases the likelihood that FDA will regulate a similar newly developed app of another company as a medical device. Moreover, companies with a competing product that has received 510(k) clearance or PMA approval are more likely to blow the whistle to FDA on companies that are marketing MHealth apps that lack 510(k) clearance or, if applicable, a PMA approval. Indeed, the uChek warning letter's "it has come to our attention" verbiage suggests that a third-party alerted FDA to the app's illegal presence in the marketplace.
FDA's action against uChek—especially as it occurred prior to issuing the final guidance on mobile medical application that is not expected until at least the end of the current federal fiscal year (September 30)—could augur in a new period of FDA regulatory action against mHealth apps that clearly are medical devices and lack the imprimatur of a required 510(k) clearance or PMA approval.3 Certainly, we can expect firms with "legal" apps to be eager to bring to FDA's attention a competitive mobile medical application being marketed without any required FDA assent.
For Further Information
If you have any questions about this Alert, please contact Lisa W. Clark, Michael A. Swit, Erin M. Duffy, any member of the mHealth, Telemedicine & Health Information Technology Practice Group, or the attorney in the firm with whom you are regularly in contact.
FDA, Draft Guidance for Industry and FDA Staff: Mobile Medical Applications, July 21, 2011, available at http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm263280.htm.
For most Class III devices, before a PMA is required, the Act requires that FDA, by regulation, require that a PMA be submitted. Until the agency "calls" for a PMA, a Class III device still must be subject to a 510(k) clearance.
Not all mHealth apps that are medical devices under the 2011 draft guidance will require a 510(k) clearance or PMA approval. For example, most Class I medical devices are exempt from the requirement for a 510(k) clearance and can be legally marketed as long as the company complies with all of the other "General Controls" applicable to any medical device firm (e.g., facility registration, device listing, Quality System Regulation (QSR) conformity, etc.). An example of a mobile medical application that falls under Class I and does not require a 510(k) is the "Medical Device Data System" (MDDS), which FDA placed in Class I in prior to issuing the 2011 draft guidance (see 76 Fed. Reg. 8637; February 15, 2011).