Establishment Registration Requirements - Combination Product

A

AnnieB

#1
Here's the case:
A Drug/device combination product is regulated as a drug. The device portion and the drug portion R&D are done by the same organization. That R&D group functions as the "specification developer" for the device portion. If that's the only device-related activity that happens at that site, is it necessary to register that site as a device establishment? If so, classified how?
Discuss.
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Here's the case:
A Drug/device combination product is regulated as a drug. The device portion and the drug portion R&D are done by the same organization. That R&D group functions as the "specification developer" for the device portion. If that's the only device-related activity that happens at that site, is it necessary to register that site as a device establishment? If so, classified how?
Discuss.
Hi,

In my understanding they qualify as medical devices specification developers, which fall under "manufacturers", and hence should register as such. some QSR exemptions may apply - consult specification developers' guidance available on the FDA website.

I'm not an expert on FDA drug regulation, therefore I can't really say if "regulated as a drug" overrides that, but from a medical devices perspective that's the deal. For what it's worth, I tend to think that if you'd have a bit of both worlds then the FDA would expect to see (at least) a bit of both worlds' regulations met.

Cheers,
Ronen.
 
A

AnnieB

#3
I agree with everything you said, but -- if the product will be submitted under an NDA, not a 510(k) or PMA, you won't have a device listing, so how exactly do you register as a device establishment?
 
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