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. Although FDA reportedly has approached app developers in the past about obtaining 510(k) clearances for their products, this is the first time that FDA published an enforcement letter sent to an app developer. Mobile app watchers (including the author of this post), commented that the letter appeared to be intended as an educational tool for the industry, potentially signaling stronger oversight for apps that fall into the categories FDA intends to regulate.
On one hand, the letter was unremarkable—at least in its application of basic device principles to Biosense’s product. Biosense marketed the “uCheck” app, which was used with various types of urine dipsticks for the “qualitative and semi-quantitative determination of urine analytes including glucose, urobilinogen, pH, ketone, blood, protein, bilirubin, nitrite, leukocyte, and specific gravity.” FDA observed that the app functioned as an automated strip reader, falling squarely within the definition of a device.
On the other hand, the letter was notable in several respects. It comes in advance of a final guidance on mobile medical apps, which FDA has said will be published before the end of the fiscal year. The letter, therefore, may signal that app developers should not expect FDA to exercise enforcement discretion toward the industry while it finalizes its mobile medical app policies.