> The currently available objective evidence is not sufficient to conclude whether or not there is a widespread public health concern related to servicing, including by third party servicers, of medical devices that would justify imposing additional/different, burdensome regulatory requirements at this time. Rather, the objective evidence indicates that many OEMs and third party entities provide high quality, safe, and effective servicing of medical devices.
https://www.fda.gov/media/113431/download
From my personal experience poking at a CPAP machine, there's nothing magical about it. All the sensors and active elements I could track down are available from the respective manufacturers in large quantities. The CPU is a freaking off the shelf STM32F4 with the jtag header still on the board. This is not some impossible to debug hyper-integrated design.
The oldest devices I serviced run on Windows 3.1 and still work fine. There's a touchscreen mono CRT that runs on some custom build of Windows 3.1 in daily use at that office. I use Windows 98 daily.
The latter part is interesting, as public side of FDA filings doesn't have all the V&V filings. I suspect that's why FDA is less sanguine about re-manufacturing.