Devices intended to be reprocessed and used on more than one patient are required to be directly marked with a unique device identifier (UDI). 21 C.F.R. § 801.45. If, however, the direct marking “would interfere with the safety or effectiveness of the device,” the regulation provides an exception from the requirement. 21 C.F.R. § 801.45(d)(1).
The exception in the regulation does not depend on which type of premarket review the device underwent, i.e., de novo classification, 510(k) notification, premarket approval (PMA) or biologics license application (BLA) approval. FDA recently issued a draft guidance, however, that—intentionally or unintentionally— appears to make just this distinction.
In Unique Device Identification: Direct Marking of Devices (June 26, 2015), FDA states that when a device has been cleared through the 510(k) or de novo process, the sponsor should “conduct analysis and/or testing to determine whether direct marking could significantly affect the safety or effectiveness of the device” and document the decision in the design history file (DHF). Draft Guidance, at 7. The draft guidance then states that, if the direct marking would interfere with the safety or effectiveness of the device, the exception would apply. If the company nevertheless chooses to directly mark the device, then a new 510(k) would be required.
The process described above is how the decision-making process ideally should proceed for all devices, regardless of classification or regulatory pathway. First, the manufacturer decides whether directly marking the device will affect safety or effectiveness. If so, that decision is documented in the DHF, and the company can take advantage of the exception and not directly mark the device. If the company still chooses to directly mark the device, doing so will require a new 510(k), or PMA or BLA supplement. If the manufacturer determines that directly marking the device will not affect safety or effectiveness, then the device must be directly marked, and no premarket submission is required, e.g., no new 510(k) or PMA or BLA supplement.
The draft guidance, however, is ambiguous as to whether this decision making process is the same for all devices. As an initial matter, to address whether directly marking a device would require a new 510(k), PMA supplement, or BLA supplement, FDA split the answer in two, depending on the regulatory pathway of the device subject to the direct marking requirement. As discussed above, it first addressed the process with respect to products cleared through the de novo or 510(k) process.
The draft guidance then specifically addresses devices approved in a PMA or BLA. This additional discussion is ambiguous, and seems to be saying that devices approved through a PMA or BLA cannot take advantage of the exception.
For instance, in the discussion of 510(k) or de novo devices, the draft guidance explicitly says that if the manufacturer determines the direct marking would affect the safety or effectiveness, the manufacturer can “make use” of the exception that would permit the manufacturer not to directly mark the device. But there is no such language in the discussion of devices that are PMA or BLA approved. Instead, the draft guidance states that if adding a UDI direct marking would affect the safety or effectiveness of the device, the addition of the direct marking “will” require a supplemental PMA or BLA. Unlike the paragraph discussing devices cleared through the 510(k) or de novo process, the draft guidance does not state that the manufacturer may make use of the exception.
If this reading is correct, the draft guidance appears to say that a manufacturer of a PMA or BLA cannot take advantage of the exception, as it could if the device were cleared through the 510(k) or de novo process. As noted, this language is not very clear, and this outcome may not have been intended. If that is the case, any final guidance issued should clarify that the exception to the direct marking requirement applies equally to all devices, regardless of classification or regulatory pathway.