
How the FDA process is biased against new technology - nkurz
http://mobihealthnews.com/46693/is-the-fda-process-biased-against-new-technology/print/
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Turing_Machine
Hmm... the MelaFind thing doesn't sound risk-free to me. If it's approved,
there are two ways that could go wrong:

1) Doesn't identify a real cancer (risk is obvious)

2) Falsely identifies a non-cancerous mole as cancerous (exposes patients to
unnecessary surgery, which always carries some risk, even with something as
minor as a typical mole removal).

In both of those cases there's going to be a specific, identifiable dead or
injured patient (or family of same) raising hell, creating a PR black eye for
the FDA.

If the software _isn 't_ approved, people will probably also die, but they
_won 't be as identifiable_, at least not nearly as easily. They likely won't
even know.

I'm not saying that this is a good situation ('cause it isn't), but that's how
things are. I don't think they're biased against technology, I think they're
biased against risk (specifically, risk that might reflect badly on the FDA).

