Hello,
As the title thread say, is a new 510k required when changing a manufacturing location?
I am looking on the FDA site under the guidance around whether a 510k is required for changes to an existing device, but it doesn't seem to specifically cover change of manufacturing locations.
For reference the guidance I am looking at is:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080235.htm
If anybody could provide an alternative link that provides guidance on the matter above that would be appreciated.
Thanks
As the title thread say, is a new 510k required when changing a manufacturing location?
I am looking on the FDA site under the guidance around whether a 510k is required for changes to an existing device, but it doesn't seem to specifically cover change of manufacturing locations.
For reference the guidance I am looking at is:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080235.htm
If anybody could provide an alternative link that provides guidance on the matter above that would be appreciated.
Thanks