On June 26, 2015, FDA released a draft guidance document providing further clarification on the direct marking requirements associated with the unique device identifier (UDI) requirements. Notably, this guidance is still in draft form and therefore technically not in effect. That being said, it does provide considerable insight into the agency’s thinking on application of the direct marking requirements. This guidance supplements other recently released guidance documents clarifying other aspects of the UDI rule finalized in September 2013 and builds on the body of information released by the agency as it addresses the practical challenges of UDI implementation through the issuance of exception and extensions.
While nearly all medical devices are subject to labeling their medical devices with UDI information, certain categories of devices are also subject to directly marking the device itself with UDI information. This latest draft guidance clarifies when such direct marking is required.
Clarification of “Multiple Use” and “Reprocessing”
The final UDI rule and associated regulations state that devices must have a “permanent marking providing the UDI on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use.”1 FDA clarifies in this draft guidance document the “multiple use” provision as well as the definition of reprocessing for purposes of the UDI direct marking requirement. Specifically, the draft guidance states that devices which are “intended to be used more than once” are those products which are intended for use on or by different patients. Accordingly, devices used more than once by the same person, would not meet this element of the definition and do not need to be directly marked.
Regarding application of the term “reprocessing,” the agency references the definition of reprocessing contained in its guidance document, Reprocessing Medical Devices in Health Care Settings: Validated Methods and Labeling (March 17, 2015) in that it is a “validated process used to render a medical device, which has been previously used or contaminated, fit for subsequent use.” The agency goes on to state that while it typically considers reprocessing to involve cleaning, disinfection or sterilization, it will apply an abbreviated definition for purposes of requiring a device to be directly marked. Specifically, the draft guidance states that it if a device is reprocessed between patients by cleaning alone, this would not trigger direct marking requirements. More extensive reprocessing procedures such as disinfection or sterilization would be necessary to require application of the direct marking requirements. The Federal Register notice accompanying release of this draft guidance document specifically requests that interested parties comment on FDA’s definition of "reprocessing" in this context, particularly whether "'reprocessing' for purposes of UDI direct marking requirements [should] include cleaning alone without subsequent disinfection and/or sterilization of the device?" Interested parties may comment on these specific questions and other aspects of the guidance through September 24, 2015.
Addition of UDI Information to a Device
If a device meets both of these definitions of "intended to be used more than once" and "reprocessed" and does not otherwise have an exception from complying with the UDI requirements2, the device must be directly marked with UDI information, meaning that a UDI is permanently affixed to the device itself. The UDI should be applied in a manner that it would last the expected usage life of the device including the interim expected reprocessing.
When adding the UDI information directly to a device, companies must carefully consider the impact of the marking on the safety and efficacy of the device. If the safety or effectiveness of the device could be impacted, a supplemental regulatory submission may ordinarily be required. As holders of 510(k) notices are well aware, changes to a device that could significantly affect safety or effectiveness warrant the submission of a new 510(k) notice to address the changes. However, this draft guidance notes that for devices cleared through the 510(k) pathway or de novo process, if a company determines that direct marking could significantly affect the safety or effectiveness of the device, the device is exempt from direct marking of UDI information on the device3. Accordingly, if the company reasonably determines that direct marking could significantly impact safety or effectiveness of a device, then direct marking of that device would not be required. Companies should document their analysis and conclusions in the device design history file where they determine direct marking is not required in case FDA challenges this regulatory position4. Notably, this exception is not available for devices subject to PMA or BLA requirements, and direct marking may therefore trigger filing of an appropriate regulatory supplement, which would need to be accompanied by the appropriate user fee.
With regard to the timing of direct marking requirements, the following dates, as originally described in the final rule, apply. Notably, these date supplement the date requirements for applying UDI information to the device labels and listing UDI information in the Global UDI Database (GUDID).
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Although as per this draft guidance FDA is seeking stakeholder opinion with regard to how to apply the term “reprocessing,” there has been no extension issued for the compliance dates while FDA determines the appropriate definition of reprocessed devices for purposes of direct marking requirements. Accordingly, manufacturers of devices which are only cleaned between uses in different patients must carefully consider the application of direct marking requirements and the possibility, albeit remote, that FDA could change course and decide to apply the direct marking requirement to these devices with a limited or no extension for implementation.
Additional Guidance Forthcoming
As noted above, interested parties may comment on the draft guidance through September 24, 2015. FDA will likely take several months to finalize this guidance, and while there may be minor changes in the way the guidance is applied, particularly with regarding to the definition of the term reprocessing, sweeping changes are unlikely. The agency has also indicated that it intends to release an additional Frequently Asked Questions guidance regarding the implementation of the UDI requirements, in follow-up to the first volume of FAQs released in August 2014.