For the second time this week, the FDA posted something related to the things I pay the most attention to. Earlier this week it was about the DSCSA. This time it was a draft guidance for comment on a proposed delay in enforcement of a small part of the Unique Device Identification (UDI) final rule. I’ve seen a lot of mentions around the internet about this new FDA posting but none of them really explain it very well (including the FDA). I’d like to take a stab.
Way back in around 1970 the FDA created a numbering system for drugs and one for devices. The one for drugs was called the National Drug Code, the NDC system many of us are well aware of today (see “ Anatomy Of The National Drug Code“). But the one for devices, which was almost identical to the NDC, was called the National Health Related Item Code, or NHRIC.
The reason all drugs today are identified with an NDC today is because Congress mandated it back in the 1970s. The reason very few people have ever heard of the NHRIC as a medical device identifier is because Congress did NOT mandate it back then. Who knows why? My best guess is, politics. That’s what they do.
So over the last 45 or so years, companies in the U.S. drug supply chain and payment/reimbursement chain have enjoyed a standardized identifier for drug packages. But over those same years, companies in the U.S. medical devices supply chain and payment/reimbursement chain have been living an identification nightmare. Without a standardized identifier, identification mistakes happen all the time, and they cause treatment errors, ordering errors, stocking errors and payment/reimbursement errors.
The UDI final rule was intended to fix the cause of those nightmares. The FDA laid out a series of deadlines that required medical device manufacturers to begin marking their device packaging for a given class of device–and the device itself in some situations–with a new standardized identifier: the UDI. This would eliminate the problem of multiple device classes having the exact same identifier that the unregulated identification scheme resulted in. Every device class would have its own unique identifier.
I’ve written a fair amount about the UDI technology and related topics over the last few years because I find it very interesting how it has been done. Here are just a few:
- FDA Proposed UDI: A Revolution In Number Assignment
- FDA Proposed UDI: AIDC Requirements
- UDI And The Approaching End Of The NDC
- Requesting an Extension/Exception to the U.S. FDA UDI Rules
- FDA Posts Small Entity Compliance Guide For UDI and GUDID
It’s not serialization. It is just bringing the medical device world into the modern era with a class identifier that has many of the benefits the NDC brought to the pharmaceutical world back in the 1970s.
Now here’s the problem with the UDI final rule that this brand new proposed guidance would attempt to address. A number of device manufacturers actually went ahead and voluntarily marked their products with an NHRIC code back in the 1970s. And some of them are still identified that way. A few other manufacturers actually identified their devices with an NDC, with the FDA’s blessing back then.
For more on NHRIC codes and the history of the NDC system, see:
The UDI final rule addressed the use of these obsolete codes by providing a date, after which those identifiers (referred to in the final rule text as “legacy identification numbers”, see section 801.57) would need to be replaced with a UDI.
Here is the entire section 801.57 of the UDI Final Rule:
(a) On the date your device must bear a unique device identifier (UDI) on its label, any National Health-Related Item Code (NHRIC) or National Drug Code (NDC) number assigned to that device is rescinded, and you may no longer provide an NHRIC or NDC number on the label of your device or on any device package.
(b) If your device is not required to bear a UDI on its label, any NHRIC or NDC number assigned to that device is rescinded as of September 24, 2018, and beginning on that date, you may no longer provide an NHRIC or NDC number of the label of your device or on any device package.
(c) A labeler who has been assigned an FDA labeler code to facilitate use of NHRIC or NDC numbers may continue to use that labeler code under a system for the issuance of UDIs, provided that—
(1) Such use is consistent with the framework of the issuing agency that operates that system; and
(2) No later than September 24, 2014, the labeler submits, and obtains FDA approval of, a request for continued use of the assigned labeler code. A request for continued use of an assigned labeler code must be submitted by email to: email@example.com, or by correspondence to: UDI Regulatory Policy Support, Center for Devices and Radiological Health, Food and Drug Administration, Bldg. 66, Rm. 3303, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002.
(d) Each request for continued use of an assigned labeler code must provide—
(1) The name, mailing address, email address, and phone number of the labeler who is currently using the labeler code;
(2) The owner/operator account identification used by the labeler to submit registration and listing information using FDA’s Unified Registration and Listing System (FURLS).
(3) The FDA labeler code that the labeler wants to continue using.”
What is unfortunate about this section is that it treats NHRIC and NDC identifiers as if they are just as bad as identifiers that companies just made up themselves. But this is not the case. NHRIC and NDC identifiers used on medical devices should not have the problem where the same identifier is being used on other medical devices. That’s because the NHRIC and NDC were way ahead of their time (or, way ahead of our time anyway…how about, way ahead of UDI’s time).
They solved the problem for the devices they were assigned to, which the UDI program is now attempting to solve for all devices, and they did it in almost the same way as UDI will do it. So there is no pressing reason for those particular identifiers to be changed on an aggressive schedule.
In fact, pharmacies and their claims processors who make use of these NHRIC and NDC numbers (or reimbursement codes that are based on them) are very concerned about confusion and potential errors introduced when the transition to UDI codes occurs. (Although, it seems to me that will happen no matter when you make that change.)
THE NEW DRAFT GUIDANCE
The new draft guidance, which may eventually become official and would then be something you could follow, if/when it is finalized, would relax the deadlines related to the existing use of NHRIC and NDC codes on medical devices. It would accomplish that by establishing the FDA’s intent not to enforce those requirements until a new deadline.
- class III devices,
- devices licensed under the Public Health Services (PHS) Act,
- class II devices, and
- implantable, life-supporting or life-sustaining devices,
manufactured and labeled prior to September 24, 2018, the date of enforcement would be pushed out from September 24, 2018 to September 24, 2021, a three year delay.
The FDA is also proposing to extend the deadline for which companies could request continued use of an FDA-issued labeler code, which would be the basis of any valid NHRIC or NDC codes, but could also be used to generate new UDI codes, from September 24, 2014 (which passed 17 months ago) to September 24, 2018.
In effect, if your company is one of those forward-looking companies who recognized the value of the NHRIC and NDC systems way back in the 1970s or later, you will be given a little more time to switch to the UDI system. And for good reason, I think.
The FDA is asking for public comments on their proposed guidance document. You have until April 4, 2016 to submit your comments to docket number FDA-2016-D-0199-0001 at http://www.regulations.gov/#!documentDetail;D=FDA-2016-D-0199-0001.
If this essay appealed to you then you should attend the 2016 UDI Conference in Baltimore, MD on April 18-19. It is led by the FDA UDI Team and it is endorsed by industry stakeholders. You shouldn’t miss it!