The FDA's report on third party servicing says this:
> 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.
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 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.