G
Hello all,
The scenario that just came up for me is this;
Company A would like to sell a finished Class II product into the US that does not have a 510k. They would like to sell it to Company B that is a distributor, but only to customers outside the US.
My response would be that this is not allowed based on information from the guidance document below:
from http://www.fda.gov/MedicalDevices/D...ce/ImportingandExportingDevices/ucm050126.htm
Import for Export
A firm may import device parts, components, subassemblies, etc. for further processing or incorporation into unapproved devices which are to be subsequently exported. A firm may not import a finished unapproved device without prior marketing clearance, even if the device is to be imported solely for subsequent export. The terms "further processing" and "incorporation" as detailed in the Regulatory Procedures Manual19 is rather broad in its interpretation. For example, a device imported for further packaging or labeling would fall into this category; a device which is simply stored without any further action prior to export would not fall into this category.
My guess is that Company A needs a 510k, along with listing and registration, to sell the finished device to anybody within the US borders, regardless if the customer is going to use it or export it. However, if the device was a Class I exempt finished product, then only listing and registration would suffice. Does this sound right to everyone? Or am I missing something obvious?
The scenario that just came up for me is this;
Company A would like to sell a finished Class II product into the US that does not have a 510k. They would like to sell it to Company B that is a distributor, but only to customers outside the US.
My response would be that this is not allowed based on information from the guidance document below:
from http://www.fda.gov/MedicalDevices/D...ce/ImportingandExportingDevices/ucm050126.htm
Import for Export
A firm may import device parts, components, subassemblies, etc. for further processing or incorporation into unapproved devices which are to be subsequently exported. A firm may not import a finished unapproved device without prior marketing clearance, even if the device is to be imported solely for subsequent export. The terms "further processing" and "incorporation" as detailed in the Regulatory Procedures Manual19 is rather broad in its interpretation. For example, a device imported for further packaging or labeling would fall into this category; a device which is simply stored without any further action prior to export would not fall into this category.
My guess is that Company A needs a 510k, along with listing and registration, to sell the finished device to anybody within the US borders, regardless if the customer is going to use it or export it. However, if the device was a Class I exempt finished product, then only listing and registration would suffice. Does this sound right to everyone? Or am I missing something obvious?