It's not yet clear how the US Food and Drug Administration's (FDA) unique device identification (UDI) rule will be remembered. After all, it has not yet been implemented. But if the rule is remembered for something, it may well be for the lengthy process it went through to eventually obtain approval, as well as the extensive and unexplained delays it went through along the way.
Now, for the first time, the public is getting something of a glimpse at the behind-the-scenes struggle between FDA and the Office of Management and Budget's (OMB) Office of Information and Regulatory Affairs (OIRA), whose duty is to approve all regulations before they are promulgated.
The UDI rule was first called for under the 2007 Food and Drug Administration Amendments Act (FDAAA). In concept-and now in reality-the system is intended to allow regulators and healthcare providers to track and trace medical devices through standardized markings and barcode labeling. The idea is that if a device experienced a problem, it would be easy for regulators to determine where those devices had been distributed to, and doctors could incorporate device data into electronic and physical health records.
But if the intent of regulators was to see the rule published soon, they were out of luck. It languished for years before a draft was finally submitted to OIRA on 11 July 2011. Once there, however, the rule was seemingly stuck. Eventually legislators and the medical device industry got involved, and on 3 July 2012-one year after submitting the rule to OMB-FDA finally published its proposed UDI rule.
After receiving more industry input, FDA finally put together a final rule, which it then sent off to OMB in 2013.
Then, it waited.
It waited long enough that legislators and advocacy groups again began to express their impatience, writing to OMB that the delays were unacceptable.
Whether or not that tactic had any effect is unclear, but on 20 September 2013, the agency finally released its final UDI rule to the public.
And while some in industry may simply be glad to finally have a sense of certainty about the rule and its effects, others wondering aloud about what took so long now have an answer of sorts.
In a posting to FDA's Federal Register docket on 25 October 2013, the agency posted a version of the final rule reflecting changes between what it had submitted to OMB and what had eventually been released to the public.
Those changes are extensive, affecting many of the 165 pages of the final rule.
Some are cosmetic, reflecting a different-some might say more careful-choice of words. Take the following example on page five of the final rule. FDA's original wording of a sentence states:
"In addition, FDA expects that the UDIs in patients' Electronic Health Records (EHRs) and Personal Health Records (PHRs) will substantially improve our ability to identify the specific devices used on, or implanted into, patients. This information will support a host of activities including provider access to patient-specific device information, links to other important clinical detail, the ability to communicate actionable information to relevant stakeholders, especially patients and providers, the collection of important information about experiences with devices, and support for further registry development. Further, this information will support a number of postmarket surveillance activities-for example, allowing for rapid identification of risks and benefits associated with a device within specific subpopulations."
However, OMB made substantial efforts to this seemingly benign statement of purpose, which now reads:
"In addition, while not required, FDA anticipates that providers will include UDIs of a wide variety of devices in patients' Electronic Health Records (EHRs) and Personal Health Records (PHRs). This information will strengthen the health care community's ability to identify the specific devices patients and will improve response to postmarket surveillance activities, including adverse event reporting and recalls. For example, this information will contribute to the rapid identification of risks and benefits associated with a device within specific subpopulations."
This pattern of changes is continued throughout the document, with most substantial pages reflecting at least one change. To cite an example on page seven, OMB elaborates on the specific definition of the term "labeler"; on page 17, OMB deletes a reference to labelers; on page 23, OMB deletes an explanation of why FDA made changes to its kit marking requirements.
Worth the Wait?
In all, the document contains hundreds of changes, though few seem to be in any way substantial, reflecting instead a greater level of clarity or nuance.
Ultimately, the question may be whether the sum result of the changes were worth the months of delays. The answer may well lie in what each person finds most useful in the guidance. If the added detail was of benefit to your ability to understand, OMB's efforts may well justify the wait. If not, this document may be exhibit A in how OMB and OIRA are contributing to unnecessary delays.
The Redlined UDI Rule (Exhibit B)