Hi Maria,
In a nutshell, the business/regulatory model proposed by your sales representative has merit and, if properly configured/managed, can generally work to meet the FDA establishment registration and device listing requirements of 21 CFR Part 807. Indeed, FDA's establishment registration and device listing obligations are primarily driven by the operations in which a firm is engaged, and only secondarily (if at all, depending on the circumstances) by who obtained the 510(k) clearance.
It is true that FDA's standard approach is to reflexively view the 510(k) owner as the owner/controller of the device specifications (i.e., as the Part 807 "manufacturer" or "specification developer"), and thus to view that firm as being ultimately responsible for assuring proper 21 CFR Part 820 GMP compliance and ongoing Part 807 compliance for the subject device. Yet transfer of "ownership" / control of a 510(k) (and ultimate accountability for GMP) is a well-established business/regulatory scenario that FDA accepts as long as the proper notifications/adjustments are made to assure FDA knows who is the current Part 807 "manufacturer", "specification developer", and "contract manufacturer".
For example, a U.S. firm could, via the aforesaid FDA notifications/adjustments, take on the Part 807 role of being, as applicable, either the responsible "manufacturer" or "specification developer", and can have the subject device fabricated outside the U.S. by a Part 807 "contract manufacturer". If the finished devices in that scenario are imported into the U.S. by the U.S. firm and distributed from that same site into U.S. interstate commerce (whether directly to end users or to distributors), then there would be no requirement for registration of an "initial importer".
But remember that, in such a scenario, the U.S. site becomes the actual responsible "manufacturer" or "specification developer" who is held ultimately accountable for finished device design, fabrication, ongoing quality, etc., etc. That means, for example, that FDA's first (and typically only) focus for GMP inspections will be the U.S site. It also means that the U.S. site is ultimately responsible for critical regulatory events like recalls, 510(k) letters to file, and responding to inquiries from FDA's adverse event monitoring group.
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Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
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Original Message:
Sent: 20-Feb-2023 08:49
From: Maria Ida Iacono
Subject: US importer for foreign manufacturer - registration
Hi all,
We are a device manufacturer based in France. We also recently created a US incorporated company and opened a physical office in the US.
We got the 510k clearance (owned by the French company) for our device and we are currently working on registration and listing to sell the device in US. We are a little bit puzzled by the different roles that need to be identified in the FDA registration page. The easy option is that we (French company) are identified as the foreign manufacturer and the US company (or a third party) can be the initial importer and US agent.
We got challenged by our sales representative which proposed a different configuration that, according to him, doesn't require an initial importer:
The US company might be the one owning the asset and the French one would be identified as a contract manufacturer. I am not sure this option makes sense (since France owns the 510k) and whether in any case it changes anything concerning the need of an importer.
It would be great if you can share your own experience or thoughts.
Thanks in advance
Maria
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Maria Ida Iacono
Paris
France
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