April 13, 2023

UDI for IVD Devices Used In-House: Part 3

For those that would say that the part of an IVD assay/test used only in a manufacturer’s in-house lab isn’t in “commercial distribution” and thus asserting that UDI requirements don’t apply: That is definitely a thought provoking stance.  But I’m thinking that such an interpretation might be overuse of a regulatory technicality that skirts the fundamental intent of U.S. medical device UDI law and implementing regulations (though I offer a possible way around that later in this post).  The UDI regulation’s transition dates and the definition of “labeler” are indeed contingent on the longstanding term “commercial distribution”.  Yet on the other hand, I’ve always taken notice of FDA’s more holistic and very plain UDI interpretations such as, “The label of every medical device shall bear a unique device identifier (UDI)” [21 CFR Part 801], and like, “All devices, as defined by 21 USC 321(h), are subject to the requirements of the UDI Rule, unless an exception or alternative has been granted.” [FDA UDI FAQ Vo. 1].  So, I’m still careful to distinguish those more primary UDI interpretations from the lower level requirements aimed at establishing which party (the labeler who intends commercial distribution) is responsible for meeting the UDI requirements.  I explain more about the intent of “commercial distribution” later in this post.

We are always left with the fundamental UDI intent/requirement demanding that the health care community and the public be able to rely on UDI to definitively and rapidly identify (e.g., via the GUDID, via adverse event reports, via manufacturer communications, etc.) the devices by which they are impacted.  Indeed, if we don’t have UDI traceability of an IVD assay/test that is used to affect clinical decision making, then the basic intentions of the UDI requirements are undermined, if not compromised all together. For example, in the commonplace IVD hazardous situation where an IVD gives false positive/negative results leading to improper clinical decisions: If such an IVD can’t be identified in the GUDID or adverse event reports, then I’d say such a scenario is a failure to comply with the basic intent of U.S. medical device UDI law and implementing regulations (see the UDI regulation preamble, e.g., at 78 FR 58786).

Another angle for me is that I’m used to working with IVDs whose reagents are formulated specifically for the particular IVD assay/test. In that case, the assay/test and its reagents are, for regulatory purposes, an ensemble that together make up the finished regulated IVD subject to applicable regulatory controls including, but not limited to, UDI compliance. From a regulatory standpoint, such an assay/test and its reagents are generally inseparable (as with any finished device consisting of multiple functional parts).  For example, FDA’s UDI helpdesk stated to me that a component (such as an IVD reagent), “…is not a finished device, is not cleared or approved independently from the finished device, and does not require a UDI…”  This shows for UDI purposes the aforesaid inseparability of a finished device and its components; and also shows that UDI requirements don’t apply to components apart from the finished device’s UDI.  And again, in my humble opinion, it certainly doesn’t obviate the basic UDI requirement for traceability of the finished device from manufacturing through distribution to patient use (see more about that below).

Accordingly, due to the regulatory inseparability of a finished device and its component parts, it seems for the purposes of UDI that if such an IVD’s reagents are placed into commercial distribution, then that IVD is itself generally placed into commercial distribution.  In general, no commercial medical device intended for human clinical use (such as an IVD to test human clinical samples at a manufacturer’s in-house lab) can be without a UDI.  Moreover, the assay/test component of such an IVD is certainly being used commercially and thus seems to be in commercial distribution. On that note, I’d also say that distribution of the IVD assay/test from the manufacturer’s production area to its in-house clinical lab location doesn’t clearly meet the intent of the regulatory exemption “internal transfer of a device between establishments within the same parent, subsidiary, or affiliate company” (a key commercial distribution exemption incorporated by reference from Part 807 into the UDI regulation).

Again, I stay mindful that the UDI requirements are ultimately aimed at serving the safety needs of the marketplace.  Consequently, IVDs whose results are used by healthcare facilities for clinical decision making are certainly no exception, regardless of where the IVD testing is actually run.  This is driven by the aforesaid fundamental traceability intentions of UDI law and regulations. FDA repeatedly says it established the UDI system for adequately identifying medical devices sold in the United States from manufacturing through distribution to patient use.  I’d say this remains the case even when the “patient use” of an IVD device involves remote locational use of the assay/test for testing the patient’s samples.  The need for UDI assay/test traceability, for example in times of false negatives/positives, doesn’t go away just because the test was run at the manufacturer’s in-house lab.

Now…all this said…it may be feasible to realize a UDI exemption for certain LDTs (Laboratory Developed Tests) based on FDA enforcement discretion for LDTs.  But as alluded to before, if such an LDT isn’t clearly restricted to use only at the IVD manufacturer’s qualified in-house lab, then such a device could generally be disqualified from LDT classification and enforcement discretion.  And I’m also not sure if an IVD device can qualify for LDT classification when part of it [e.g., its reagent(s)] is sent out to health care facilities for clinician use as part of the test.  In addition, FDA’s requirements for ASRs also need to be factored into the overall regulatory strategy to be sure the final UDI strategy is compliant.  Similarly, if IVD reagents are categorized as “accessories” separate from the parent IVD device (thus making them separate devices in their own right for regulatory purposes), then that might also be an avenue of leverage as part of a compliant UDI strategy where an LDT doesn’t bear a UDI.