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A Regulatory App-ening

Wed, Oct 31, 2012 | Peter Pitts

It was nice being at a meeting of regulatory professionals where "ED" meant something other than the expected.

Specifically, I was at the annual RAPS meeting in Seattle where the theme of the conference was "Elevate" (as in "raise the level of your game) -- and "ED" referred to "enforcement discretion."

FDA judgment was certainly on the minds of panelists (myself included) during the session on mobile apps as medical devices. At present, there are some 17,828 healthcare and fitness apps and 14,558 that can be deemed “medical.” As Vice President Biden said, “It’s a big f**kin’ deal.”

But when is an app a medical device and when is it not? Not surprisingly, it depends.

Does the app replace paper-based data collection (for example from a blood glucose meter), or does it bring to bear the power of an algorithm that takes raw data and turns it into a diagnosis with treatment recommendations?

What is the level of impact the app might have on a patient's condition. Is the app designed to assist in patient self-management?

Is the app an accessory to a regulated medical device?

Many questions, all of which lead us back to the question of enforcement discretion.

Consider the Draft Guidance for Industry and Food and Drug Administration Staff - Mobile Medical Applications  issued on: July 21, 2011 – specifically, footnotes 12 and 13:

(12) … the FDA intends to exercise its discretion to decline to pursue enforcement actions for violations of the FD&C Act and applicable regulations by a manufacturer of a mobile medical app, as specified in this guidance. This does not constitute a change in the requirements of the FD&C Act or any applicable regulations. 

(13) The FDA's review of these products indicates that the majority of these other mobile apps that may meet the definition of a medical device have functionality either to automate common medical knowledge available in the medical literature or to allow individuals to self-manage their disease or condition. Many of these mobile medical apps also automate common clinician's diagnostic and treatment tasks using simple general purpose tools, including spreadsheets, timers, or other general computer applications, by performing logging and tracking. For example, mobile medical apps that: log, track, and graph manually-entered (keyed in) data that lead to reminders or alarms; act as data viewers for patient education; organize, store, and display personal health data, such as lab results, doctor visits, dosages, calories consumed, etc.; or allow for general dose over the counter (OTC) lookups and use drug labeling to provide information that is typically available on a drug label, e.g., acetaminophen dosage for children and adults.

Now consider the “Mobile medical apps Proposed Scope for Oversight” issued by CDRH. It’s a pyramid divided into three parts:

The top of the pyramid includes mobile medical apps that are traditional medical devices or a part or an extension of a traditional medical device. Clearly within the scope of being regulated as medical devices.

The middle section includes patient self- management apps and simple tracking or trending apps not intended for treating/adjusting medication. This is the area, as defined by CDRH, for enforcement discretion

The bottom section are devices that are not deemed “mobile medical apps” and, as such, have no regulatory requirements.

FYI, per SEC. 201(h)  [321] of FD&C Act:

(a) the term "device" means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is

(1)  recognized in the official National Formulary, or the United  States Pharmacopeia, or any supplement to them,

(2)  intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

(3)  intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its principal intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its principal intended purposes.

A light regulatory hand allows for innovation to flourish. But will CDRH be flexible enough in its approach to disruptive app-based technologies. "Signs point to yes" -- but developers seeking greater predictability are only somewhat assuaged by such a Magic 8 Ball approach to agency policy.

We're in early days.  

Another "ED" variable is the intended use of an app -- something that is the responsibility of the developer, not the FDA. And discretion is the better part of valor. In short, to thine own self be true.

And what about "human factors" such as user/device interface or the environment in which that interface takes place? Bedroom or operating room? What about user-error mitigation?

And then there's the issue of validation testing.

We've come a long way from the "popsicle-stick-or-tongue-depressor" conversation -- and we've got a long way to go.  As Walter O'Malley (the man who moved the Brooklyn Dodgers to Los Angeles) once opined, "The future is just one damned thing after another."

Something to be thankful for.