FDA's Bakul Patel

Last June in a draft guidance document, the FDA proposed to further de-regulate a specific type of health software, which included a number of mobile medical apps and telehealth platforms, from FDA-registered Class 1 devices to an unregulated status. Last week the FDA moved to finalize that guidance, building on a spate of recent guidances that both make clear where regulatory lines for health software already exist and move some healthtech categories into unregulated territory.

The most recent final guidance specifically relates to MDDS software, which the FDA deregulated from Class 2 to Class 1 in 2011. MDDS are systems designed and marketed to transfer, store, convert according to preset specifications, or display medical device data without controlling or altering the function or parameters of any connected medical device.

Examples of health software platforms that have class 1 medical device clearance as an MDDS include Validic’s healthcare data integration platform and Qualcomm’s 2net platform for home health data. Another digital health product, Glooko’s MeterSync cable and companion logbook app originally started out as a class I MDDS device, but the company added additional functionality that bumped it up to a class II 510(k) clearance, which allowed it to begin offering more analysis of the collected health data. 

"Now FDA has exempted the software from all FDA regulation, and indeed swept in image management software," Epstein Becker's Brad Thompson told MobiHealthNews in an email. "The implications are profound, both for MDDS type software, but also for what it suggests about the future for health information technology generally. FDA is quite earnestly working to ensure that it uses the lightest regulatory touch appropriate for software."

When the FDA first proposed this further deregulation of MDDS software, FDA senior policy advisor Bakul Patel penned a blog post to explain the move:

“Why would we do that?” he wrote at the time. “Since our 2011 action, we’ve been working with two other federal agencies that oversee health IT – The Office of the National Coordinator for Health IT (ONC) and the Department of Health and Human Services, and the Federal Communications Commission (FCC) on a proposed risk-based regulatory framework for health IT that promotes innovation, protects patient safety, and avoids regulatory duplication. In the course of our work on the proposed framework, we sought extensive public feedback. And we listened.”

Given the MDDS definition above, it's clear that this group is related to the medical device accessory category, especially for mobile medical apps. FDA's recent draft guidance on accessory devices is, therefore, relevant. The FDA seems to agree as it is hosting a webinar later this month to discuss the MDDS final guidance, the accessory draft guidance, and the general wellness draft guidance.

Soon after Apple announced its HealthKit offering the FDA added a new kind of mobile medical app that it said it would not regulate as a medical device. The FDA's description squared with Apple's plans for HealthKit, and also read like a specific example of an MDDS:

"Mobile apps that allows a user to collect, log, track and trend data such as blood glucose, blood pressure, heart rate, weight or other data from a device to eventually share with a heath care provider, or upload it to an online (cloud) database, personal or electronic health record. [Added June 11, 2014]."