4 ms·
It seems to me like the biggest problem is implantable devices vs external devices. Anything that would require surgery to recall should have much more strenuou
by bwilliams18 11y ago
It seems to me like the biggest problem is implantable devices vs external devices. Anything that would require surgery to recall should have much more strenuous testing than something you could simply remove and replace without seeing a doctor.
Especially because so many of these implantable devices end up in older people where the risks of complications from surgery go up so much.
- seehafer 11y agoBut they do, and for the authors of this op-ed to try and insinuate otherwise is massively dishonest. Most implantable devices are what is known as Class III: the highest risk that FDA assigns. Accordingly, they go through the most stringent approval process, and they most definitely require multiple clinical trials.