4 ms·
The author makes it sound like this is a bad thing, its not. Clinical trials are extremely expensive, if every device manufacturer had to do a clinical trial ma
by not_the_fda 3y ago
The author makes it sound like this is a bad thing, its not. Clinical trials are extremely expensive, if every device manufacturer had to do a clinical trial many devices would never see the light of day.
This is a cost vs benefit trade-off. A 510k is not an easy process to get through and is still very expensive and requires an enormous amount of documentation, paper work, and justification.
If a device harms a patient, it become a reportable event, and the FDA will come swooping down and shut you down if you are not properly documenting and mitigating hazards.
The alternative is fewer medical devices saving lives.
- wcedmisten 3y agoHi, author here! I totally agree there's a cost-benefit tradeoff to be made. I think the 510k process seems appropriate for low-risk devices like latex gloves and bandages. My concern is mostly around the class II devices cleared through this process, such as the recently recalled Philips CPAP machines, which resulted in 561 deaths. [1] Philips also knew about complaints without informing the FDA. [2] [1]: https://www.cbsnews.com/news/fda-sleep-apnea-philips-recall-cpap/ https://www.cbsnews.com/news/fda-sleep-apnea-philips-recall-... [2]: https://www.propublica.org/article/philips-kept-warnings-about-dangerous-cpaps-secret-profits-soared https://www.propublica.org/article/philips-kept-warnings-abo...