alt Hacker NewsHang on, what about the part where the FDA only approved the thing for a 5 year use and essentially pushed the manufacturer into liability if they worked on it after that period? Maybe that’s the issue that needs repairing first.
Replies
tomrod • 10/11/2024
Your point is valid, and is improved when we recognize it's not an either/or blame game when acknowledging the parts of the system that need improvement for failures like this person experienced.
anigbrowl • 10/12/2024
Or, you know, the company works with both the FDA and the customer to iron out this legal wrinkle instead of taking a zero-sum approach.
It doesn't sound like a hard and fast rule. It seems like it's whatever the manufacturer asks for in terms of "intended working life." This _seems_ to be the original FDA certification for the device:
https://www.accessdata.fda.gov/cdrh_docs/reviews/den130034.p...
The problem here, of course, is it's not the device itself, but the simple remote control peripheral that is designed to switch device operating modes.
The FDA should force manufacturers of "two piece" systems like this to have backup controls on the device itself and to exclude these non-medical components designed for control from any regulation covering "intended design life."
It seems like a daffy middle ground that the FDA lets exist and manufacturers take advantage of when they can.