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1. is not intended to acquire, process, or analyze a medical image or
a signal from an in-vitro diagnostic device or a pattern or signal
from a signal acquisition system;
2. is intended to display, analyze, or print medical information about
a patient or other medical information, like clinical practice
guidelines;
3. is intended to support or provide recommendations to a health care
professional about prevention, diagnosis, or treatment of a disease
or condition; and
4. is intended to enable health care professionals to independently
review th e basis for the software’s recommendations, so professionals
do not primarily rely on the recommendations when making a
clinical diagnosis or treatment decision.
Categorically exempting certain CDS from FDA regulation can
be tricky. To address this issue, the FDA released draft guidance in
December 2017 titled “Clinical and Patient Decision Support Software.”
In the Guidance, the FDA provided various examples of CDS that
would and would not meet the definition of a medical device. Here is
one example of CDS that would not be considered a medical device:
“Software that uses rule-based tools that compare patient-specific
signs, symptoms, or results with available practice guidelines
(institutions-based or academic/clinical society-based) to recommend
condition specific diagnostic tests, investigations or therapy.”
Conversely, the FDA provided examples of CDS that would be
considered medical devices. Many of these examples involved complex
functionality and focused on software functions that would be used
directly to treat/diagnose a condition. For example, the following CDS
would be considered a medical device:
“Software that uses a patient’s image sets (e.g., computed tomography
(CT), magnetic resonance (MR) to create an individual treatment
plan for patients undergoing radiation therapy treatment with
external beam or brachytherapy, and the health care professional is
intended to rely primarily on the treatment recommendations in
determining the radiation therapy plan for the individual patient.”
The FDA focused its interpretation in the Guidance on whether the
CDS user “should be able to reach the same recommendation on his or
her own without relying prim arily on the software function.” If yes, it
would not be considered a device; if no, it would be considered a device.
With the closure of public comments in July 2018, it will be
interesting to see how FDA addresses this issue. As the development of
healthcare-related software progresses, new technologies may eclipse
the conventional ways of diagnosis and treatment and may, in fact,
become the new norm. If that occurs, will the FDA require these new
technologies to follow the conventional procedures for medical device
approval, or will different pathways to approval be developed?
Author: Kevin Rudolph - Shriners Hospitals for Children
SEPT - OCT 2018
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