Regulatory Update
regulated device or are used as an accessory to a regulated de-
vice. One of the more important aspects of the guidance is the
additional clarity FDA has provided regarding what constitutes
‘health and wellness,’ and that enforcement discretion will also
apply to health and wellness apps targeted at patients with spe-
cific diseases. Additionally, FDA has reaffirmed its position that
it will not regulate manufacturers of mobile platforms or owners
of app marketplaces as medical device manufacturers, as long as
they do not explicitly market their products for medical device
purposes. This guidance will enable the industry to innovate with
the expectation that FDA regulatory oversight will only be ap-
plied when necessary to protect the public health. It is truly one
of the few bright spots in what is currently a very challenging
regulatory climate.”
“The final guidance on mobile apps is quite helpful,” said
Bruce A. MacFarlane, Ph.D., medical research scientist in the reg-
ulatory department of NAMSA, a medical research organization
based in Northwood, Ohio. “It’s a significant improvement over
the draft guidance. But some manufacturers will still find it dif-
ficult to categorize some medical mobile apps because many mo-
bile app developers are inexperienced with regulation, and also
because there will always be devices that fall into an area that’s
difficult to categorize. FDA has categorized mobile apps into apps
that will be under regulation enforced by the agency; apps where
FDA will exercise enforcement discretion; and then non-medical
apps. The guidance is helpful in giving a number of examples to
illustrate the different categories, but we still expect many com-
panies will need support and help in interpreting the guidance.
Some companies will do well to make direct contact with FDA to
get a determination. Medical mobile app developers need to be
knowledgeable about FDA’s software guidances to assure they
have appropriate documentation of software development and
validation when they are filing 510(k)s.”
The second major decision to come out of the FDA regarding
health I T this year, also in September, was its final rule on a unique
device identification (UDI) system. The idea behind the system is
to have a method by which every device is easily traceable, there-
by allowing physicians and the FDA to better track adverse events
and even to pre-empt disaster like the failure of a pacemaker.
According to the FDA, the UDI system consists of two core items:
a unique number assigned by the device manufacturer to the ver-
sion or model of a device, called the UDI. This identifier also will
include production-specific information such as the product’s lot
or batch number, expiration date, and manufacturing date when
that information appears on the label. The second component is a
publicly searchable database administered by the FDA called the
Global Unique Device Identification Database (GUDID) that will
serve as a reference catalogue for every device with an identifier.
The rule is careful to note that no identifying patient information
will be stored in this device information center.
“The UDI final rule is going to have a real significant impact
on medical device manufacturers,” said Valynda Machen, medi-
cal research manager, regulatory, at NAMSA. “We now have less
than one year until Class III devices have to be compliant with
the final rule, and that means they have to have the UDI informa-
tion on the label of the device and all the saleable configurations.
That means they have to change their date format if it’s not in
compliance and they have to have all this info uploaded into the
GUDID database. The majority of manufacturers haven’t started
on this yet, and there’s a lot of information to be gathered and
verified. They’re going to need some cross-functional teams in
their organizations to pull this off, which will be critical to their
success. It’s going to be really easy to underestimate the complex-
ity of implementing UDI in their organizations.”
From a manufacturing standpoint, the practical issue of inte-
grating the UDI into products will be of real consideration.
“I think [the rule] is a good thing, but I also see problems
down the line,” said George Stone, quality engineering manager
at Stratos Product Development LLC, a Seattle, Washington-
based full-system product engineering and design consultancy.
“That’s always the question of how an OEM would want the UDI
integrated into its product. Do they want the serial number in
the software or on the hardware? Some of the products we work
on are products that get absorbed into larger systems, and [our
clients] are going to want to know what role the identifier plays
in the larger system.”
The idea James Bamford was referencing in his criticism of
the overlarge Utah data collection storage facility was President
Dwight D. Eisenhower’s “military industrial complex,” the likes
of which, some say, has now come into existence in the United
States. In an address delivered three days before he left office in
1961, Eisenhower warned against the construction of a central
complex that would prove so large that it would give unwarrant-
ed power to one entity.
“In the councils of government, we must guard against the ac-
quisition of unwarranted influence, whether sought or unsought,
by the military-industrial complex,” President Eisenhower said.
“The potential for the disastrous rise of misplaced power exists
and will persist.”
It may be a little bit alarmist to compare the centralization of
health data to the United States military industrial complex, on
which America spends more money than the next 10 countries on
the list of largest defense spending combined. However, it does
remain that the FDA is the only agency governing patient and hospital data that will inevitably all be collected and stored in this one
big database, or cloud, or whatever form it ends up taking.
An Agency in Flux
Outside of the two major September guidances/rules that will
have a significant effect on the medtech industry—particularly
the health IT sector—in the months and years to come, the FDA
did not put out a large number of guidances this year. However,
in the past two to three years, the number of total guidances totaled more than 50, forcing medical device companies to fight to
stay abreast of rapid-fire new rules and regulations.
