The Journal of mHealth Vol 1 Issue 5 (Oct 2014) | Page 37

The Evolving US mHealth Regulatory Landscape
risk products. If finalised, these changes
will have significant impact on mhealth
developers.
510(k) Exempt Devices Draft
Guidance
On August 1, 2014, the FDA issued
other draft guidance exempting certain
devices from pre-marketing notification
requirements, commonly referred to as a
510(K). There are a number of products that fall into the mHealth category.
For example, thermometers, stetho-

claims. Today, we have a better understanding of how lifestyle decisions can
impact our health and certain disease and
conditions. We also have access to a lot
more information about health status
through the use of wearable devices and
mobile technologies. This is empowering
individuals to more proactively manage
their health. But it is also blurring the
line between those regulated products
that are intended to diagnosis and manage diseases and conditions and those
intended to help manage health and wellness.

The regulatory framework for the
mHealth market and broader health
IT industry is dynamic and continues
to evolve....Many mHealth and health
IT products are part of complex,
interconnected systems which require
a refined regulatory approach.
scopes, talking first-aid kits, hearing aids,
and exercise equipment were included.
The FDA indicated that the proposed
devices were sufficiently well understood
and did not pose risks that require 510(k)
review to assure their safety and effectiveness. While these devices are still
subject to other regulatory requirements,
the FDA is not requiring manufacturers
to comply with 510(k) requirements for
these devices while the guidance is being
finalised.
Other Guidance
The mhealth industry eagerly awaits
guidance on two other crucial issues:
The accessory rule and wel