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Hospital-Developed, In-House Device - FDA Clearance?

OccamMan

Starting to get Involved
#1
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!
 

Al Rosen

Staff member
Super Moderator
#4
You should seek the advice of an attorney as there may be local statutes that prohibit the use of uncleared devices.
 

Watchcat

Quite Involved in Discussions
#5
Al, that's an interesting point. Do you know of a state with this type of statute? I would be interest to read one.
 

OccamMan

Starting to get Involved
#6
You should seek the advice of an attorney as there may be local statutes that prohibit the use of uncleared devices.
Good point - our state tends to be more stringent than most, so something could well exist. We will definitely get attorney opinion before proceeding. But sometimes we can save effort by pointing them in the right direction.
 

JeantheBigone

Quite Involved in Discussions
#9
I would have thought that as long as the hospital is not introducing the device into interstate commerce, that FDA has no authority to regulate it.
 

Watchcat

Quite Involved in Discussions
#10
Jean, yes, that would seem to make sense. Usually not a good sign. :)

As I understand it, the legal definition of "introducing into interstate commerce," is not as straightforward as it might seem....unlike most legal definitions, lol. FDA has taken the position that it has the authority to regulate LDTs, which it defines as "designed, manufactured and used within a single laboratory." Presumably most laboratories do not straddle a state line, so how it resolves this with "interstate commerce," I don't know. Congress might get around to resolving it some day. Or maybe not.
 
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