Re:FDA Warning Letter to 23andMe
by HeyLaughingBoy on Monday November 25, 2013 @07:52PM
(#6798296)
That really doesn't matter. The responsibility for correct results falls on the Device Manufacturer (in this case 23&me), not on the physician that ordered the test.
I work for a large Medical Device manufacturer and questions like this come up all the time when we do Hazard Analysis. While the physician (or lab rules) may require a second confirmatory test, and that may give us warm fuzzies, it really can't be considered to be a hazard mitigation. It's still up to the manufacturer to not make the mistake in the first place.
I work for a large Medical Device manufacturer and questions like this come up all the time when we do Hazard Analysis. While the physician (or lab rules) may require a second confirmatory test, and that may give us warm fuzzies, it really can't be considered to be a hazard mitigation. It's still up to the manufacturer to not make the mistake in the first place.