Export & Import of Unapproved Device in USA for Service Purpose Only

N

nzinzuwadia

#1
Hello Cove members,

I have a hypothetical scenario and need your help to address it:

If a Medical device firm has an approved device in Canada but not in USA, can this device be imported into USA for Service purpose only i.e. to say if the device malfunctions at the end-user facility in Canada, will it be possible for the service/distributor firm in USA to legally bring the device into USA and repair the device and return to the end-user?

Is it possible for a firm to export an unapproved device (in USA) to another country (legally approved) and does it fall under section 801(e) (1) of the FD&C act?

Thanks
 
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M

MIREGMGR

#2
Regarding (a), I think you'll have to ask FDA, maybe starting by calling DSMICA. I don't think that question is documented.

Regarding (b), it's a complicated question. Among other things, it matters to what country you want to export. Some relevant amendments to the law are discussed in a guidance at http ://www .fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/ucm148005.htm - OBSOLETE BROKEN 404 LINK(s) UNLINKED
 
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