As our colleagues discussed in a previous post on InsideMedicalDevices, FDA took its first publicly announced enforcement action against a mobile app developer on May 22, issuing an “It Has Come to Our Attention Letter” to India-based app developer, Biosense Technologies. The letter received extensive media coverage, and the mHealth sector was immediately abuzz with interest (and concern) about its implications.
Commentators observed that the letter appeared to be intended, in large part, as an educational tool for industry. As such, it’s appropriate to ask: what lessons should industry draw? Although single enforcement actions do not always serve as reliable predictors of future actions, the letter offers a handful of key takeaways:
- Public and political pressure can spur FDA action. Biosense’s app hardly was flying under the radar. The app received media coverage after being featured at a TED conference, and it was called out in trade press and in testimony to the House Energy and Commerce Committee. These factors likely helped push FDA to finally take a public enforcement action.
- Lack of a final guidance document doesn’t preclude enforcement. Although FDA’s draft guidance document on mobile medical apps was “distributed for comment purposes only,” the principles FDA proposed were on display in the Biosense enforcement letter. The uCheck app had the effect of transforming “the mobile platform into a medical device”—causing FDA to conclude that “the phone and device as a whole functions as an automated strip reader.” It thus fell into one of the categories of apps that FDA stated that it would regulate.
- FDA will second-guess how an app is listed. Though not mentioned in the enforcement letter, the uCheck app is listed in FDA’s establishment registration and device listing database as a class I “[a]utomated urinalysis system” under 21 C.F.R. § 862.2900, defined as a “device intended to measure certain of the physical properties and chemical constituents of urine by procedures that duplicate manual urinalysis systems.” Though not an inaccurate description of the device’s overall function, FDA’s letter observed that the app is intended to work with certain reagent strips that were cleared as part of class II test systems, and FDA offered an example 510(k) for a similar strip-reading device. Thus, when determining the proper classification for an app, developers should thoroughly research how similar devices are regulated—as classification regulations that appear applicable on first blush may not capture all of a device’s functionalities. Developers also should be aware of the “.9 regulations” contained in each device classification Part, which state that devices used for certain purposes (including “diabetes management”) are not exempt from the requirement of 510(k) premarket notification.