Hi all,
we (party A) are an engineering service provider. We are ISO 13485 certified but not (yet) QSR compliant. Our US customer (Party B) wants to approach US market first. We develop (design) but don not manufacture the device. Manufacturing to where we will transfer the design is party C and they are 21 CFR 820 compliant. Device and design owner will be party B, our US customer.
According to 21 CFR 807 (Foreign Establishments Registration and Listing) we are evaluating if we, as the design developer, have to register at FDA and if we have to build a QSR according to CFR 820. But they do not mention anything about design developer, only about manufacturer. Does anyone have an idea what applies to us?
Thank you