Careful engineering and rigorous testing does not require FDA approval. Hackers and makers can do their own rigorous testing and publish their methodology, whic

Careful engineering and rigorous testing does not require FDA approval. Hackers and makers can do their own rigorous testing and publish their methodology, which can be scrutinized by peer review. What's unlikely is that a DIY production scheme can ensure consistent manufacturing quality, since the careful, rigorous hackers are not going to be making this for everyone.