The Journal of mHealth Vol 2 Issue 4 (August) - Page 32
Walking a Fine Regulatory Line
Walking a Fine Regulatory Line:
Selling General Purpose IT Equipment
for Specific mHealth Applications
By Bradley Merrill Thompson
Tech companies have noticed the
mhealth market. They have products
like smart phones, routers, and other
communications equipment that have
uses in many different industries, including healthcare. They want to enter the
healthcare market but they wish to avoid
regulation by the U.S. Food & Drug
Unfortunately, many of those companies
struggle to understand the definition of
a regulated “medical device” and the
degree to which they can promote their
products for medical use without crossing the line into FDA territory. Many, for
example, want to know whether, in their
promotional materials, they can discuss
medical uses without having to comply
with U.S. medical device requirements.
The answer is yes, but they need to walk
a fine line.
1. It all starts with intended use
The foundation of medical device law
is the concept of intended use. Paraphrasing the U.S. statute a bit, the line
that defines a regulated medical device is
drawn based on how the manufacturer
intends its customer to use the product.
Generally speaking, if the manufacturer
intends the customer to use the product
in the diagnosis or treatment of disease
or other conditions, FDA will regulate
the product as a medical device.
This definition tends to frustrate people
who like clear-cut rules. Compared to a
rule, for example, that the Federal Communications Commission regulates all
nonfederal use of the radio frequency
(RF) portion of the electromagnetic
spectrum, the medical device definition
is certainly less precise. But the principles behind it are relatively clear.
Intent is established through evidence.
Think of any murder trial you’ve seen
on TV. The government establishes the
intent of the alleged murderer through
evidence-- evidence that typically
includes statements by the defendant
that reveal his intent, or actions from
which the judge or jury can infer intent.
Establishing intent for the use of medical -related products is likewise evidencebased. The government first and foremost looks at the promotional claims the
manufacturer makes, and the uses of the
product those claims suggest.
2. Understanding general versus
specific intended uses
Here is where things get interesting. Interpreting words has never been a simple
exercise. The fact is words have lots of
different meanings, and when you string
them together in various ways they can
have very subtle differences in meaning.
Let’s say I have a mobile app that uses the
camera and the screen on a smart phone
to view stuff at a 10 X magnification. In
promoting the sale of that app, there are
hundreds of ways I might describe it but
let’s look at two.
First, I could call it a “magnifying glass
app.” Its function is to make stuff look
Second, I could call it a “dermatology
magnifying glass that is useful in looking at moles to assess them for possible
Under U.S. law, clearly I can sell an app
that I promote as a magnifying glass
without any need to comply with FDA
requirements. That app quite simply is
not a medical device.
At this point, a philosophy major may be
thinking that, using syllogistic logic, if an
app that can be used to magnify anything
is lawful without FDA compliance, then
an app that could be used in any manner
that is consistent with that intended use
would likewise not require FDA compliance. If the philosophy major also
majored in math, he may think in terms
of sets, and conclude that any product
intended to fall within the set defined
by the general purpose magnifying glass
claim should likewise be lawful.
The problem is: the philosopher would
be wrong. FDA does not regulate the
first intended use but does regulate the
second, even though logically it fits
within the first.
FDA is not run by philosophers, but
rather by clinicians. The more specific
intended use is regulated even though
the general use is not because there are
risks associated with the specific claim
that are not present in the general claim.
FDA explains its thinking in a guidance
document entitled “General/Specific
Intended Use” issued in November
1998. While that guidance does a very