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Comments on “Pacif-i”
Posts » Pacif-i » Comments » Comment
Gabriela Hromis@ghromis · WisePeach.com
I am pregnant now, so devices like this are highly relevant to me. This sounds great, however I am wondering how accurate it is. Electronic thermometers are class II FDA devices, and so should be approved by the FDA as such. However, I can't find on their website that it is approved, which is an issue with most of these techie monitoring devices (movement mo… See more
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Kirstin Hancock@kirstinhancock · Co-founder, Blue Maestro
@ghromis Hi Gabriela, not all health thermometers need to be FDA cleared. Also under the S. 510 predicate process "clinical trials" as that term is commonly understood is not required, even for class II devices. Pacif-i falls within the new draft guidance published by the FDA on general wellness devices where FDA clearance is not required if the device rep… See more
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Edin Vejzovic@edinvejzovic · Designer, marketing-er, and a talker.
@kirstinhancock @ghromis There is no such thing as "a baby smart device not needed to be checked by the FDA ", Especially the baby products. The rubber could be toxic, the electronic device inside could be radiating, or easy to extract and swallow by a baby, and since you took so much time to explain why you went around the FDA approval, something is suspici… See more
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Kirstin Hancock@kirstinhancock · Co-founder, Blue Maestro
@edinvejzovic @ghromis Baby products do need to be checked by the FDA. They certainly need to comply with safety standards (as Pacif-i does) and this may require testing for toxicity and the like (as Pacif-i has been).
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Edin Vejzovic@edinvejzovic · Designer, marketing-er, and a talker.
@kirstinhancock @ghromis Glad it's that way, in that case , best of luck with the project. I missunderstood it from the comment :) .
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