Anyone here have experience with designing an implantable device? I have a crazy idea of using the die and antenna from an NFC yubikey for an implanted Universal Second Factor (U2F). The nice thing about the U2F spec is that the same device works for a large number of services, and at least on Yubikeys they can be provisioned over NFC rather than requiring USB.
Cheers,
~H
Can you say “FDA Approved Medical Device” be prepared with $$$ and time if it is to be sold.
I’m not selling it, and do you really thing anything from a place like Dangerous Things has some form of FDA approval?
I would bet the packaging does not say approved for human use. Doing something and doing something that is FDA approved can be two very different things.
If it isn’t sold and for yourself, nothing they can really do.
Well, yeah.
The call for advice here is because one can shove an uncoated piece of
metal into their hands, or one can choose to rather still make a sterile
/biosafe coating regardless of regulatory requirements.
Lots of good articles on this site that might help.
https://www.sciencedirect.com/topics/medicine-and-dentistry/medical-implant