Busy week for FDA and mobile health, but no final guidelines yet

By Brian Dolan
04:45 am

Brian Dolan, Editor, MobiHealthNewsSo far this past week was a busy one for those at the FDA's device office focused on mobile medical app regulation. No, it didn't release its final guidance document yet, even though Congress gave the agency a verbal lashing more than three months ago now. Still, the agency has had an unusually busy week.

Apart from the typical -- like Rock Health alum Nephosity securing FDA 510(k) clearance for its iPad-based imaging app -- the FDA likely read the news Tuesday morning that tricorder-like medical device maker Scanadu launched a crowdfunding campaign through IndieGoGo that will put a pre-FDA clearance device into the hands of consumers as a means to crowdtest the device and gather some of the needed data to secure that FDA clearance.

Scanadu's CEO Walter DeBrouwer understands that this might be an unprecedented move, but he also believes that crowdsourcing platforms are going to push industry to rethink old processes. Scanadu's Scout device isn't likely to ship until at least March 2014 so it will take some time before we see how this one plays out, but after less than two hours of the crowdfunding campaign going live, Scanadu hit its goal of $100,000 raised.

The FDA hasn't reacted to the Scanadu news, but it did finally get around to a urine analysis app that made headlines after being demo'd in a TED talk earlier this year. The FDA rarely makes a public show of proactively enforcing its mobile medical app regulations, but this week the agency made what was perhaps an unprecedented move by sending the app developer a letter informing it that its app might require 510(k) clearance or at least should be registered as a Class 1 device.

Biosense's urinanalysis app uChek was using other medical devices -- urine test strips -- that were only cleared to be interpreted by the human eye, not a smartphone app's camera or algorithm. EpsteinBecker's Bradley Merrill Thompson, who is also the co-founder of the mHealth Regulatory Coalition and a longtime MobiHealthNews columnist, has been pointing to the uChek app for the past few months as an example of an app that the FDA should be enforcing its medical device guidelines against. Thompson even made mention of the app during his testimony at a congressional hearing in February.

One official announcement made by the FDA this past week was a posting in the Federal Register that declared "ingestible event markers" (IEMs), commonly called digital pills, to be Class II medical devices with some special controls. The new categorization is a result of the 510(k) clearance of Proteus Digital Health's IEM paving the way with its clearance last summer.

While the post in the Federal Register is high profile, it's really just a formality. Digital pills have been designated as a Class II device category since July 2012 thanks to Proteus, so the Federal Register posting is just a reminder that digital pills really arrived as a new regulated device category almost a year ago now. So, all you other digital pill developers, you have your predicate device.

Speaking of decisions that should have been made years ago... where are those final guidelines?


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