CPAPtalk.com

MaskedMechanic wrote:Since when does the Food and Drug Administration control software? Software is now a controlled medical device? I am reluctant to believe that software is really controlled by FDA.

I am back working in the medical devices field, and even though I am a mechanical engineer, I am very aware of the FDA involvment in software verification.

Yes indeed the FDA controls software for medical devices. In fact software verification for the FDA is one of the most difficult parts of product development these days.
Although you wouldn't know it by the sloppy interfaces in CPAP software. But at least its SUPPOSED to be accurate.....even if its incomprehensible at times.

Saying they can't sell this monitoring software to individuals due to the FDA is a reach though.

sthnreb wrote: I assume they purchase it lots cheaper in volume and who knows, would Respironics lie??

I don't know I wasn't close enough to see their lips move! Jim