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Design developer - 21 CFR 807 - do we need to register?

Daliane

Starting to get Involved
#1
Hi all,
we (party A) are an EU engineering service provider. We are ISO 13485 certified but not (yet) QSR 21 CFR 820 compliant. Our US customer (Party B) wants to approach US market first. We develop (design) a medical class II b device for them, but do 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. Our US customer want our Quality Management System to be 21 CFR 820 compliant in case of FDA inspection. But I am not sure if we have to.
At the Guidance "Who must register, list and pay the fee" they do not mention anything about design developer, only about manufacturer. Does anyone have an idea what applies to us?

Thank you
 
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