this post was submitted on 27 Jan 2024
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My first attempt at a commercial 3D print: an asthma inhaler body that can flip into a slimmer form so it doesnt jut out and dug into legs or tear pants. What do you guys think?

Edit: Hi all, it seems like the general consensus is that this is a dangerous product. I really believed that I was making something helpful but that may not be the case. I have decided to take down the listing from Cults3D. Thank you for your feedback.

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[–] RegalPotoo@lemmy.world 60 points 9 months ago (11 children)

Design looks slick and I'm glad it's solving a problem that you have, but as someone who works in medtech I have to say - actually selling this as a product would probably be classed as a "Bold Move".

The product you are marketing is controlling the dispensing of a drug, so is pretty unambiguously a Medical Device. The details vary by country and exactly which category this ends up in, but you are almost certainly required by law to seek approval from the regulators for any jurisdiction that you are marketing this product in. I'm not totally clear if "selling designs to produce a Device" would attract the same level of scrutiny as "selling a Device", but generally I'd recommend not screwing with the FDA.

[–] Marechan@lemmy.world 4 points 9 months ago

I had to go through the regulations regarding plastic packaging and delivery systems of drugs for work and, yeah, you would have to go through a lot of testing and certifications for it to FDA compliant, especially for a inhaler.

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