April 4, 2023

FDA PMA Stakeholder Logistics Strategy

There is much to be addressed with this topic.  To help us get pointed in the right direction, here are some key principles:

• In order to, as some informally say, 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 PMA or other types like Class I 510(k)-exempt, 510(k), de novo, etc.] 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 Applicant B’s proposed PMA device MD2 is “comparable” to a different legally marketed device marketed by a different firm Applicant A, then, as a general rule, Applicant B’s device MD2 will still require its own separate PMA approval.  Deviations from this general rule are, for example, if MD2 is sponsored by Applicant A and is just a supplementary modification of Applicant A’s own legally marketed MD1 via MD2 PMA Supplement.  Another route is if Applicant A has divested MD1 to Applicant B such that Applicant B becomes the sponsor/owner of MD1 and then sponsors a PMA supplement of MD1 to realize MD2.  But if MD2 and MD1 are in fact different devices (though comparable), then such alternatives aren’t available for the PMA approval of MD2.  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.  These are just some hypotheticals; there could be other organic variables/scenarios to consider in your particular case.

• 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 an overarching “umbrella company”, or it could be Applicant A or B, or a different party.  But the applicant, whoever it is, and as distinguished from the submission correspondent, will generally 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.

• Elaborating further, 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, like recalls, warning letters, etc.  Therefore, would it be beneficial to identify an intermediary business partner like a US agent or Distributor as “legal manufacturer”?  That depends on whether such entity is ready and qualified and willing to take on the initial and the perpetual ongoing weight of being the legally responsible manufacturer.

• Can an intermediary party like a U.S. Agent or Distributor or Consultant 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 such person 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 such party as the legal manufacturer, which can be contrary to FDA’s intent, such as for U.S. Agents.

• Regardless of device class or exemption status, 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.

• As a related aside, 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.