3 ms·
That's a tough one to answer. The cynic in me says probably not. That they're so focused on pharmaceuticals and "analog" medical devices that they haven't devel
by function_seven 10y ago
That's a tough one to answer. The cynic in me says probably not. That they're so focused on pharmaceuticals and "analog" medical devices that they haven't developed those capabilities.
But I also know that the FDA is a massive organization, and there's no reason they couldn't hire for this specific purpose. But then the cynic says that government pay grades may not be up to snuff.
See the HCA rollout and subsequent rewrite.
Sorry, that was a long way of writing, "I don't know".
- grogenaut 10y agoThere have been medical devices external to the body for a long time. Therac 25 (1982) is world wide web (1989). Airplanes were first flight controlled by computer in 1958, and commercially in the concorde in 1969. Think about that for a minute. There has been an official government review process for safety of computer controlled airplanes since the 70s, and a good decade for medical devices (likely earlier) 10 years earlier than the WWW existed. I think it's kind of funny that you'd think that you were doing it better than production life critical systems THAT CAN ACTUALLY KILL PEOPLE that have been around at least ten if not 30 years longer than the tech you likely (sorry assumption) base your career around.
- throwanem 10y agoUh, did you really just cite Therac 25 in favor of safety review? You do know that was the one that had a bug which slipped past review and killed some people, right? Your overall point is well taken, but maybe put a little more thought into the examples you pick to support it...
- grogenaut 10y agoI cited it as a thing that killed people and caused an industry overhaul in how things were reviewed... Remember that toyota just was forced to do somthing like this only a few years ago. I'd say the FDA has been cognizant of life threatening code for a lot longer.
- hx87 10y ago> But then the cynic says that government pay grades may not be up to snuff. If they really wanted to, they could sidestep the pay issue as every other government agency does, by hiring contractors.