News for hackers. Stuff that matters.

A comment on It's Just a Virus, the E.R. Told Him. Days Later, He Was Dead. Parent comment

Re:It's Just a Virus, the E.R. Told Him. Days Later, He Was ... by nradov on Monday October 06, 2025 @05:36PM (#45496589)
To an extent, but only if the software meets the criteria for being legally classified as a "medical device". And at the lower classification levels the regulations are very light. You don't necessarily have to prove any level of reliability or usability.

https://www.fda.gov/medical-devices/classify-your-medical-de...

[ Parent | on HN ]
Re:It's Just a Virus, the E.R. Told Him. Days Later, He Was ... by Neywiny on Monday October 06, 2025 @05:41PM (#45496634)
Ex employee of the division of imagine devices and software reliability here. I have nothing to add, and I'm not qualified to confirm or deny your comment. Just interesting to see a mention of my past life
[ Parent | on HN ]