I remember it like yesterday.
The year was 2011 and I was having coffee with a prominent med device VC. During our discussion we touched on the future of med tech and how the FDA would affect the industry. His stance was adamant “I have worked with the FDA for years and there is no way they will ever allow mobile health devices to intersect with health care!”.
Now fast forward three years.
Abriiz, our first web and mobile product has shipped. We have connected activity bands, wifi scales & are on the fast track to adding a glucose meter. Once our Abriiz app pulls the data in, we aggregate it, dashboard the trends and then apply them to the incentives chosen by our case manager partners.
Strange how a three year old opinion could still haunt me despite evidence to the contrary.
Simultaneously over the same three year period the FDA published their “Guidance for Mobile MedicalApplications” report in September of 2013. This guidance document became the first formal indication of how the Federal Government intended to regulate our mHealth sector. I’m proud to pat our team at Ideomed on the back for contributing to these regulations, together with other industry thought leaders and with key voices from The Associationfor Competitive Technology (ACT). In summary the guidelines acknowledge the risks, but also recognize the potential benefits of our expanding mHealth sector. Still, these were non-binding recommendations, a formal review of Abriiz was still submitted and pending.
Then late last week as I was opening my mail….The letter!
With drum rolls of suspense marching through my mind, I sat down with a diet coke to read what was to be our fate before the FDA.
An excerpt from what I read:
“We have reviewed the above referenced Request for Information, submitted in accordance with Section 513(g) of the Federal Food, Drug and Cosmetic Act, regarding the regulatory requirements applicable to Abriiz(r) (sic)”.
Suspense built as I read on…
“…we believe that Abriiz is a medical device as that term is defined in section 201(h)of the Act.”
Not yet exactly what we had hoped for, but…
“…we believe that Abriiz is a mobile medical application allowing a user to collect, log, track and trend data…Therefore, at this time, we do not intend to subject your device to any regulatory requirements…”
Whoo Doggy! Now that is exactly what we had hoped for!!!
Of course there are various caveats and pieces of additional information, but there was no denying the news was extraordinarily good! We are not required to undergo more costly and time consuming device classification requirements!
Given the relatively recent release of the guidelines, I recognized that we are likely one of the first companies in the nation to receive such news! As this realization was setting in, I sat back sipping the last of my diet coke and took a nice long, deep breath.
The discussion I had three years ago with my friend again resonated in my mind: “The FDA will never allow mobile health devices to intersect with health care…” And I was bolstered by the confidence that our entire team has displayed over the past few years. We stayed our course in the belief that we can indeed change the world for the better, and now today we are even further emboldened by the FDA’s visionary stance encouraging our continued plans for healthcare innovation.