Does the FDA have any regulations limiting the installation of non medical software by an end user on to an approved regulated medical device?
This is in relation to https://law.stackexchange.com/a/103990/31989 where it was mentioned that use in a situation where failure is likely to cause personal injury was a non warrented use. This being relatively common in medical device contexts.
No. The CDRH division of the FDA has no mandate to regulate end users or the practice of medicine in any way. They regulate device manufacturers. In fact, the most rigorous pathway through the Center for Devices and Radiological Health (CDRH -- the specific FDA division that regulates devices) is called "Premarket approval" because it's actually the marketing and shipping of the devices that is regulated.
More specifically, from fda.gov/media/151975/….,
"Does the FDA regulate medical services, availability of medical products, pricing and health insurance? No. The FDA does not regulate the practice of medicine, medical services, the price or availability of medical products and whether they are reimbursed by health insurance or Medicare. "
That said, the FDA should not approve a device that isn't robust, therefore if the ability of the device to safely and efficaciously do it's job, then the ability to upload software to the device might need to be removed prior to approval if the review process so indicates.
