FDA Medical device reporting (Manufacturer in US; contract manufacturer OuS)

#1
All,

A hopefully simple question.

The Specification developer/manufacturer of a medical device is listed as being in the USA, however the device is manufactured outside the US (contract manufactured) and imported in by the specification developer. When the specification developer is reporting events (3500As as the manufacturer) to the FDA, do they need to also submit an importer 3500A report?
 
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