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by not-my-account 1318 days ago
Yea - could someone shed some light on this? What would the FDA have to do with an app like this? What risk to the public could an app like this pose?

    “We had to get an independent security audit and submit it for FDA clearance”
Security audit is probably a good thing. Maybe they need FDA clearance for doctors to prescribe the usage of an app? That just seems ridiculous to me, but also right up the FDA's alley.
2 comments
tgv 1318 days ago
What if it would have worsened it? Or had unwanted side effects? That you call it an "app" doesn't mean it cannot affect your health, to state the obvious. And that's regulated territory, and with good reason.
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eropple 1318 days ago
Why is it ridiculous for a medical device to be reviewed by the governmental agency whose remit includes reviewing medical devices?
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pc86 1318 days ago
Because it's not a medical device, it's a vibrating watch.
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eropple 1318 days ago
This comment is whatever middlebrow dismissal would be, but for basic facts of U.S. law. As per the Food, Drug, and Cosmetics act of 1938, we have 21 U.S. Code §321[1]:

(1) The term “device” (except when used in paragraph (n) of this section and in sections 331(i), 343(f), 352(c), and 362(c) of this title) means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is

> (A) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,

> (B) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

> (C) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. The term “device” does not include software functions excluded pursuant to section 360j(o) of this title.

The developer of the device themselves clearly understands that this "vibrating watch" qualifies as a medical device.

[1] - https://www.law.cornell.edu/uscode/text/21/321

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