[yellers]

Hang 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.

[akira2501]

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.

[generalizations]

> It seems like it's whatever the manufacturer asks for in terms of "intended working life."

I would guess the FDA makes their certification easier or harder to pass based on how long the device is expected to last. If the 5 year lifespan is what hits the middle ground for that company between cost-of-certification and useful-product-life, then it's up to the FDA to make a longer lifespan feasible to get certified.

[MichaelZuo]

There is no part two to the certification?

Edit: Seems odd that the loophole is big enough to allow not even uploading the full documentation.

[tomrod]

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]

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.