Hi:
My question is regarding the UDI for US. My company is a medical device manufacturer of software only product (already 510k cleared). In addition we also want to bring in US the third-party device + accessories (everything is 510K cleared). For that we are packaging everything together in a new package (sort of a briefcase) whie making no changes to the devices themselves or their original manufacturer's label..That is, we are just creating a new package that contains all the hardware components needed to acquire the signal that our software analyzes.
Question:
Given that I am not the owner of these other 510Ks:
1- Should I give a UDI# to this package and then I will enter all the information related to the other devices in the package in GUDID?
2- Should I just change my FDA registration to add repacking and then register a "new device"(package conformance) with all its components, under our name and then give UDI?
3- 1+2 above?
Would really appreciate any help here.
Thanks
Daniel
My question is regarding the UDI for US. My company is a medical device manufacturer of software only product (already 510k cleared). In addition we also want to bring in US the third-party device + accessories (everything is 510K cleared). For that we are packaging everything together in a new package (sort of a briefcase) whie making no changes to the devices themselves or their original manufacturer's label..That is, we are just creating a new package that contains all the hardware components needed to acquire the signal that our software analyzes.
Question:
Given that I am not the owner of these other 510Ks:
1- Should I give a UDI# to this package and then I will enter all the information related to the other devices in the package in GUDID?
2- Should I just change my FDA registration to add repacking and then register a "new device"(package conformance) with all its components, under our name and then give UDI?
3- 1+2 above?
Would really appreciate any help here.
Thanks
Daniel