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Related anecdote: I interned for a medical device company over summer of 2015 and worked on a team that was in charge of maintaining several implantable class 3
by valine 10y ago
Related anecdote: I interned for a medical device company over summer of 2015 and worked on a team that was in charge of maintaining several implantable class 3 medical devices. The devices used a short range proprietary wireless standard to talk with a intermediary device which could be connected to via Bluetooth. One product had a pretty serious usability issue where connecting to the intermediary device could take upwards of several minutes. After the issue was discovered it took roughly an afternoon and several lines of code to fix. However, in order to provide software updates for a class 3 medical device each update needs to be individually approved by the FDA. It took 12 months from the time the fix was implemented to when the FDA allowed it to be pushed out.
- hughes 10y agoI think the word you want is "anecdote".
- valine 10y agothanks
- joshvm 10y agoWhat is the approval process? Do the FDA manually check the device (similar to FCC certification for wireless things)?
- valine 10y agoI never had the opportunity to be involved in the FDA submission process, but from what I understand the FDA does not do any testing of their own. It's the companies responsibility to prove to the FDA that their device is safe and effective. All the testing is done by the device company, carefully documented, and then reviewed by the FDA. I've heard stories that the documentation for a class 3 medical device can be upwards of 20,000 pages which are all printed and handed to the FDA in 3 ring binders.