The Journal of mHealth Vol 2 Issue 4 (August) | Page 33

Walking a Fine Regulatory Line
glass app to determine its suitability for
that purpose. That means the app must
work for that specific function. Customers are likely to rely on the claim.
3. Manufacturer intent versus
customer use
Key to understanding the concept of
intended use is appreciating that it is the
manufacturer’s intent, and not the customer’s actual use of the product, that
matters. The burden of regulatory compliance falls on the manufacturer, so it
is only fair to impose the FDA requirements when that intent crosses the regulatory line. Manufacturers cannot be held
responsible for all of the uses to which
a customer might put a product. Under
FDA’s rules, an orthopedic surgeon can
go to a hardware store to buy a saw for
a surgical procedure. FDA would have
no jurisdiction over that act. Instead,
the doctor’s conduct is a state regulatory
issue regarding physician licensing, and
a medical malpractice issue under state
tort law.
4. Promotional guardrails for
staying out of regulatory waters
To sell a general use product that includes
a medical use without complying with
FDA requirements, a tech company
needs to make sure that all the evidence
points to a general purpose use. Admittedly, that’s a bit easier said than done.
I will offer three guardrails tech manufacturers ought to observe in marketing
their general purpose products.
a. Always include context
Tech manufacturers should remember
to always present their products with an
emphasis on their general purpose functions. General purpose, generally speaking, can be communicated two different
ways.
•  First, the marketer can stay at a
very high level in its description of the
intended uses: “this cell phone is for communication purposes.” If your claims end
right there, you have no FDA issue.
•  Second, the marketer can illustrate
the general range of uses. “This cell
phone is for communication purposes
and can be used by people for personal
communications, workplace productivity, managing investments and healthrelated purposes.” While not as neat and

clean as the first example, as explained
more below, this too should work.

5. Collaborating with medical device
partners

If the health functionality is presented
in a broader context as simply one part
of an illustration, FDA typically will not
treat that as a medical device type claim.
Indeed, in the marketing arena, it’s almost
impossible to stay truly general and still
adequately convey what the product
does. Often, for example, advertisements
and packaging will include pictures of
users. The picture of the user will convey
some information, for example a business person would convey office productivity where a nurse would convey a medical purpose. The manufacturer needs to
make sure that it is always conveying the
fact that this is a general purpose article
with a wide range of applications, one of
which may be use in a medical setting.
Never skip the general use.

More and more, tech companies are collaborating, each focusing on their core
strength and collaborating with others for work outside their domain. The
temptation is for tech companies that
make general purpose IT equipment to
collaborate with medical device manufacturers, to communicate that the general purpose articles can support medical
device use. That’s fine, but do not let that
cause you, as the tech manufacturer, to
get sucked into the medical device world.

b. Avoid specific medical feature
claims
Remember the policy behind regulating medical specific claims: customers
are likely to rely on specific claims when
determining whether an article is suitable
for their own purposes. The more a tech
manufacturer touts specific features of
their general purpose article as somehow
specially or uniquely helpful to a medical
purpose, they are creating an impression
in the customer that this product has
been in fact designed and tested for the
medical purpose.
For example, a cell phone manufacturer should not promote some specific
design feature whose only purpose is to
make the cell phone compatible with an
EKG accessory. That would take the cell
phone out of the realm of a purely general use article, and make it an accessory
to the EKG device. Customers would be
entitled to rely on its functionality with
an EKG accessory.
c. Avoid medical benefit claims
In addition to avoiding medical feature claims, avoid making medical benefit claims. Don’t say, for example, that
patients who use your cell phone with
an electronic stethoscope app can better manage their arrhythmia. If you start
claiming medical type benefits to using
your general purpose product, you are
very likely crossed the line into regulated
medical device territory.

If you are a cell phone manufacturer, for
example, a company that makes a medical device app that can be used to control a blood pressure cuff, for example,
can promote the use of its app with
your cell phone, but that doesn’t mean
that you can do likewise. The app developer’s promotion does not cause the cell
phone to be regulated. But if you as the
cell phone manufacturer decide to go on
a campaign to promote the use of your
cell phone with that app, you are running
the risk of making that cell phone a regulated accessory to the app.
6. Guardrails on training and
support
After the sale, it is possible to in