I've been developing medical devices for (too) many years on the industry side and understand FDA expectations for that setting, but am now trying to understand FDA's expectations for a medical device developed by a hospital solely for in-house use. I'd deeply appreciate any information in this regard.
I recall seeing a letter or some document from FDA a few years ago which stated that FDA considers these to be medical devices under their jurisdiction, and while design controls were expected they would exercise enforcement discretion and not require clearance - but they could inspect or otherwise regulate more tightly if such a step became warranted in an individual case. Of course, I can't find that document now that I need it (if I'm even remembering it correctly).
Thanks in advance!
I recall seeing a letter or some document from FDA a few years ago which stated that FDA considers these to be medical devices under their jurisdiction, and while design controls were expected they would exercise enforcement discretion and not require clearance - but they could inspect or otherwise regulate more tightly if such a step became warranted in an individual case. Of course, I can't find that document now that I need it (if I'm even remembering it correctly).
Thanks in advance!