FDA Provides Relief to Medical Device Manufacturers Under UDI
UDI is a statutorily-mandated system designed to identify medical devices throughout distribution and use. To accomplish this goal, devices are required to bear a device “fingerprint” that can be tracked back to the manufacturer and production lot. If there is an issue with a marketed device, the identifier helps the manufacturer and FDA track the issue back to the source and contain the potential public health concern. Implementing the UDI system requires participation from not only manufacturers labeling the device with the UDI and entering data into a centralized database, it also relies upon providers at the point of care to record the UDI to maintain traceability. Given the various stakeholders involved at different points of this complex system, it’s no surprise the FDA has exercised enforcement discretion and considered exceptions, alternatives and time extensions during the phased-in UDI approach. The phases of regulation follow the UDI final rule, under which higher-risk devices are required to comply with UDI before lower-risk devices. This approach is intended to maximize public health benefits early while allowing stakeholders the opportunity to get acclimated to the mandate before subsequent phases begin and responsibilities increase.
Nevertheless, FDA issued its latest UDI discretionary policy on November 5, 2018, “Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking,” citing the system’s pervasive complexity when delaying the date on which it plans to enforce certain UDI requirements:
“FDA received a large number of inquiries from labelers of class II, class III, and [implantable, life-supporting, or life-sustaining] devices relating to those policy and technical issues. Based on experience with UDI implementation to date, FDA anticipates receiving a similarly high volume of questions from labelers of class I and unclassified devices. To fully reap the public health benefits and a return on investment of the unique device identification system, the Agency intends to focus its resources on addressing existing implementation challenges and optimizing the quality and utility of UDI data for higher-risk devices before focusing on UDI implementation issues for lower-risk devices.”
The guidance’s policy relaxes deadlines for unclassified devices, class I devices, and devices required to bear a direct mark. Direct mark refers to the requirement that devices intended to be used more than once and intended to be reprocessed before each use must bear a UDI permanently affixed to the device itself. Affixing a direct mark on these devices can be challenging due to size limitations.
Unclassified devices and class I devices represent a larger segment of the medical device market as a whole and summaries of when the FDA intends to enforce relevant UDI requirements are provided below. Keep in mind that certain policies do not apply to implantable, life-supporting, or life-sustaining (I/LS/LS) devices.
- Class I and Unclassified Devices Manufactured and Labeled on or After September 24, 2018 (other than I/LS/LS devices) - FDA does not intend to enforce standard date formatting, UDI labeling, and GUDID data submission requirements before September 24, 2020.
- Finished Class I and Unclassified Devices Manufactured and Labeled Before September 24, 2018 (other than I/LS/LS devices) – These devices are already excepted from UDI labeling and GUDID data submission requirements until September 24, 2021 under 21 CFR 801.30(a)(1). Additionally, FDA also does not intend not intend to enforce standard date format requirements before September 24, 2021.
In general, the FDA’s rationale for applying enforcement discretion to UDI requirements is insightful when considering how to frame individual requests for UDI exceptions, alternatives or time extensions. Careful analysis of UDI precedent may provide a blueprint for manufacturers to obtain FDA authorization for less burdensome UDI obligations or be excepted from UDI altogether.
Although the guidance was issued as immediately in effect because the agency determined it presents a less burdensome policy that is consistent with public health, comments may still be submitted and will be considered by FDA. If warranted, FDA may revise the guidance’s policy and timeframes in response to comments received.
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