The Journal of mHealth Vol 2 Issue 2 (Apr 2015) | 页面 21

Mobile Device Aids Cervical Cancer Detection in Low-Resource Settings
Well-Understood and Accepted
Association
I think FDA spends too little time in the
guidance explaining this concept. FDA
has a long history with the concept of
“general recognition.” While that concept is found in the FDA’s food and drug
regulations, it is not well known to people in the medical device arena.
A food additive that is “generally recognized” as safe does not need to be submitted to FDA for approval. A drug that is
“generally recognized” as safe and effective
does not need to be submitted to FDA for
approval. In those contexts, FDA has written quite a bit about what it means for a
principle to receive “general recognition.”
In the wellness guidance, FDA explains
that general acceptance means “such
associations [between adopting the
healthy lifestyle and either the risk reduction or the better coping with a chronic
disease] are typically described in peerreviewed scientific publications.” What
this means is that there must be objective
evidence that the scientific community
would say that, for example, a healthy diet
helps reduce the risk of developing type 2
diabetes. Does it mean that every single
scientist must agree? Of course not. But
the association ought to be generally (but
not necessarily universally) accepted by
the relevant scientific community, as evidenced for example by the literature.

Permitted Functionality
I’m not sure whether FDA intends
these to be words of limitation, but the
agency suggests that classic functionality in this category will include digital
health solutions that “promote, track,
and/or encourage choice(s), which, as
part of a healthy lifestyle.” I think those
will certainly turn out to be the typical
functions, but I would not discourage
creative people from thinking of other
ways to achieve the overall objective of
educating and helping people find motivation to live healthier lives.
Low Risk
An overarching requirement of this
unregulated category is the product be
low risk. Honestly, most standalone
software should qualify. The FDA seems
to be concerned about technology that
comes in contact with the body as potentially too risky to qualify for this exemption. At the same time, to pick an extreme
example, a mobile app that analyzes
a photograph of a mole to determine
whether it is melanoma would probably
not qualify as low risk. Developers will
need to use some judgment here.
Conclusion
On the whole, U.S. policymakers are
strongly encouraging digital health developers to pursue products that can help

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