This message was posted by a user wishing to remain anonymous
Original Message:
Sent: 04-Apr-2023 13:37
From: Kevin Randall
Subject: Switch of "Legal manufacturer" in USA before IDE/PMA
There is much to be addressed with these questions, and some may be too organic for Forum resolution. Accordingly, you might consider getting direct help from an outside expert(s). In the meantime, I can help you get pointed in the right direction with some key principles that seem to be germane for your case:
- In order to be "registered in the U.S.", Class III medical devices requiring Premarket Approval (PMA) require PMA approval followed by corresponding FDA Establishment Registration and Medical Device Listing by the Specification Developer and any finished device Contract Manufacturers. Such establishment registration and device listing will also apply to other associated stakeholders too, like the Initial Importer(s), Foreign Exporters, etc. Therefore, a corresponding strategy needs to be customized for each business/operational/logistics scenario.
- U.S. FDA premarket authorization [whether Class I 510(k)-exempt, 510(k), de novo, PMA] is neither linked to, nor contingent on, EU MDR CE marking conformity (though such EU MDR conformity can indirectly help). Accordingly, the subject device's CE marking status is generally moot with respect to achieving official U.S. FDA premarket approval.
- U.S. FDA PMAs are independent marketing authorizations neither linked to, nor contingent on, a different preexisting PMA approval unless the subsequent PMA approval is a supplemental PMA approval for the same legally marketed device being modified under the PMA Supplement process for that same device. In other words, even if your proposed MD1 PMA device is "comparable" to a different legally marketed MD2 device, then, as a general rule, MD1 will still require its own separate PMA approval. Deviations from this general rule are, for example, if MD1 is sponsored by Company B and is just a supplementary modification of Company B's own legally marketed MD2 via MD2 PMA Supplement. Another route is if Company B has divested MD2 to Company A such that Company A becomes the sponsor/owner of MD2 and then sponsors a PMA supplement of MD2 to realize MD1. But if MD1 and MD2 are in fact different devices (though comparable), then such alternatives aren't available for the PMA approval of MD1. For example, contrary to a section 510(k) notification, the PMA process is not based on showing substantial equivalence to a legally marketed predicate device. Instead, the PMA process is for showing that the subject device is, in its own right, intrinsically safe and effective. Again, there are too many organic variables to definitively answer here in the Forum; these are just some examples. But these principles need to be carefully considered regarding your plan, "MD2...will be used as parental model for registration purposes of MD1...".
- The FDA's PMA requirements allow any applicant to carry out the PMA obligations for a subject device as long as that applicant will fulfill its respective obligations. That applicant could be either the superior "umbrella company", or it could be Company A, or a different party. But that applicant (as distinguished from the submission correspondent) will be viewed as the legal manufacturer unless established otherwise in the PMA. Indeed, FDA says that the PMA applicant is usually the person who owns the rights, or otherwise has authorized access, to the data and other information to be submitted in support of FDA approval. This person may be an individual, partnership, corporation, association, scientific or academic establishment, government agency or organizational unit, or other legal entity. The applicant is often the inventor/developer and ultimately the manufacturer. If your plan deviates from this, then be sure to clearly explain this in the PMA application.
- The PMA applicant is generally the party that FDA will consider to the be the Specification Developer (the "legal manufacturer" using your terminology) unless otherwise notified. In practice, this means FDA will direct its reviewers' attention to that Specification Developer. In other words, the PMA acknowledgment letter, any requests for Additional Information, PMA holds, PAI correspondence and planning, responsibility for Design Control and other GMP compliance, PMA approval letter and ownership, PMA conditions of approval, etc., etc., will be directed and ascribed to that applicant. So also will post-market quality and enforcement issues, such as recalls, warning letters, etc. Therefore, would it be beneficial to announce Company B (= current US agent) as "legal manufacturer"? That depends on whether Company B is ready and qualified and willing to take on the initial and the perpetual ongoing weight of being the legally responsible manufacturer.
- Can a U.S. Agent submit a PMA on the sponsor's behalf? Yes. But in so doing, it is recommended that it be made clear to the FDA that the U.S. Agent is merely a submission correspondent, not the PMA applicant, specification developer, "legal manufacturer" etc., unless that burden (see preceding paragraph) is actually your business plan. Otherwise FDA will view the U.S. Agent as the legal manufacturer, which is contrary to FDA's intent for U.S. Agents.
- Finished device contract manufacturing sites must still have their own FDA establishment registration and device listings with FDA. The finished device contract manufacturer must still operate under a quality management system that is in compliance with 21 CFR Part 820. And for a PMA device, the finished device contract manufacturer will still be inspected by FDA during the PMA PAI process, along with the specification developer site.
- Notification regarding change in sponsor of an IDE submission will depend on when such change was made, either before the termination of the clinical investigation, or after completion of the clinical investigation. If made after, then corresponding explanation needs to be made in the corresponding section of the PMA application.
Hope this helps get you started in the right direction.
------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.
Original Message:
Sent: 03-Apr-2023 11:02
From: Anonymous Member
Subject: Switch of "Legal manufacturer" in USA before IDE/PMA
This message was posted by a user wishing to remain anonymous
Dear all,
I would like to know what you think about the following scenario for Class III medical devices planned to be registered in the US (see questions below):
Company A based in Germany as legal manufacturer acc. to (EU) MDR 2017/745 article 10 would like to register an already CE-marked Class III medical device (hereinafter MD1) in the US (also classified as Class III in US).
Company A is connected to an US located company (= Company B), both are working for a superior "umbrella company" and work already close together for US registrations of devices.
Company B already owns a PMA license for a comparable medical device (hereinafter MD2) - which will be used as parental model for registration purposes of MD1.
Initially, it was intended to register MD1 as single PMA with Company A as "legal manufacturer" in the US and Company B as designated US agent (= applicant of IDE/PMA application) (Current status: Before IDE submission).
However, the question was asked if it wouldn't be beneficial to announce Company B (= current US agent) as "legal manufacturer" for the IDE and/or PMA application and Company A as "contract manufacturer"? The idea is to save resources and money. Conclusively, no single PMA license for MD1 but an extended PMA license with MD1 and MD2 (only one license needs to be maintained), all US post-market activities at the US site and not split to several sites, ...
My assumption: As no applications were submitted to FDA yet, Company A would simply be listed as "Contract Manufacturer" as the manufacturing would still occur at Company A anyhow, and the "applicant" for the IDE and/or PMA would be Company B anyhow as the applicant need to be a US located entity. In a QAA it would be defined who "manufacturing responsibilities" would be set up in this relationship properly in compliance with US requirements.<o:p></o:p>
Now it is interesting to know what an (internal) "change" of legal manufacturing responsibilities would mean for follow up steps (which would not be a change reportable to FDA as no IDE/PMA application was submitted before), therefore my questions to you:
<o:p></o:p>
- Due short project timelines: Is there any issue by switching the "legal manufacturer" from Company A (= still manufacturing site, not US based) to Company B (= US based) for the IDE submission? In fact, there should not be any regulatory burden as Company B would act as point of contact for the agencies anyhow and act as applicant not the manufacturing site (= Company A). What are the disadvantages/advantages and working packages if this switch is performed?<o:p></o:p>
<o:p> </o:p>
- If IDE submission was done with Company A as "legal manufacturer" (= no contract manufacturer), is it possible to submit the PMA application by switching to Company B? In my opinion it should be fine – but are there any "changes to submitted documents" need to be done? I only found guidance documents applicable for already submitted/accepted PMAs or IDEs. What are the disadvantages/advantages and working packages if this switch is performed? (QAAs, …)<o:p></o:p>