Is a new 510K required for change of manufacturing location for an existing device?

neash83

Starting to get Involved
#1
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
 
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NicoleinFlorida

Inactive Registered Visitor
#2
Re: Is a new 510K required for change of manufacturing location for an existing devi

I don't think a new 510k is required for the change of manufacturing location. If the site change will not impact the safety and effectiveness of the device (according to the Flow-Chart), there is no need for a new 510k.
 
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