4 ms·
I don't really understand why "we" tolerate FDA regulating non-invasive medical devices at all.
by rdl 4y ago
I don't really understand why "we" tolerate FDA regulating non-invasive medical devices at all.
- w10-1 4y agoFDA literally only regulates labelling and claims about the devices. It then conditions the approvals on quality systems to validate the claims. It's not clear what would happen if someone made drugs or devices and sold them with no claims whatsoever.