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All systems go as US deadline for UDI medical device rule approaches: FDA fine tuning provisions

This article was originally published in SRA

Executive Summary

Jay Crowley of the Food and Drug Administration explains how the agency is faring with its mandate to introduce a unique device identification system in the US. Neena Brizmohun reports.

Momentum is gathering in the US around the imminent introduction of a rule that will require most medical devices distributed in the country to carry a unique device identifier (UDI)1.

The legislative deadline for the Food and Drug Administration to finalize the UDI rule it proposed in July 2012 is just months away. The agency is now on the final leg of dealing with the "thousands of pages of comments" it received during consultations with stakeholders, many of whom expressed concern over the practicality, usability and cost implications of certain provisions in the proposed rule.

During a webcast organized by the Regulatory Affairs Professionals Society (RAPS) on 6 February2, Jay Crowley, the FDA's senior advisor for patient safety, confirmed that the FDA was striving to finalize and publish the UDI rule by June (there appears to be confusion over whether the legislative deadline is in May or June). The rule would become effective in stages over a period of seven years. It also transpired during the webcast that the agency still has much to resolve with regard to addressing some of the concerns raised by stakeholders.

The FDA is seeking to introduce a UDI system that will improve device traceability throughout the supply chain and help the agency identify product problems more quickly, improve target recalls and improve patient safety. It has proposed a risk-based, phased-in approach to implementation, focusing on the highest-risk medical devices first and exempting low-risk devices from some or all of the requirements. With certain exceptions, under the proposed rule, a UDI would include:

  • a device identifier, which is a unique numeric or alphanumeric code specific to a device model; and

  • a production identifier, which includes the current production information for a device.

"Medical device recalls are difficult to conduct," Mr Crowley said. An analysis of medical device recalls by the US Government Accountability Office found that while firms initiated about 700 recalls per year, they "were unable to correct or remove all recalled devices even though subject to the highest risk or Class I recalls", the FDA officer noted. The GAO found that device firms do not remove unsafe devices from the market because they cannot locate all customers or devices or because customers cannot locate the devices subject to recall.

A review of Class I recalls showed that in 53% of the cases, firms were unable to correct or remove all of the faulty devices from the market. Moreover, Mr Crowley pointed out, while there are many Class I recalls, "we have significantly more Class II and III recalls and believe that it's even more difficult in those cases to find those devices." Once UDI is in place, Mr Crowley said, "it will facilitate the granular identification of devices electronically so that we know where devices are, we know which facilities have which devices… which patients have which implants or [are] treated with which device."

The FDA issued its proposed UDI system on 10 July last year; the accompanying public consultation closed on 7 November3. On 19 November, the agency announced it was amending the proposed rule to comply with implementation deadlines of the Food and Drug Administration Safety and Innovation Act (FDASIA), which was signed into law on 9 July4. The FDA has received over 260 submissions from the public commenting on the proposed rule, with stakeholders recommending a number of amendments5.

OTC device exemption to go?

One change to the proposed rule that the FDA is considering relates to its suggestion to exempt completely from the UDI rule over-the-counter (OTC) devices. "We received a tremendous amount of comments [to the proposed regulation] on this particular exemption," Mr Crowley said.

The objections came mainly from the "healthcare space and those that deal with reimbursement and distribution of devices" who are worried that the exemption would mean that important information on OTC devices would not be logged in the Global UDI database (GUDID) that the agency is establishing to accompany the new UDI system.

The FDA had originally proposed exempting OTC retail devices from the UDI rule as such devices generally carry a universal product code (UPC). "It was thought that putting a UDI on devices that also had a UPC would serve very little purpose," Mr Crowley explained.

However, the general consensus from stakeholders is that while a UPC would be a sufficient UDI surrogate, exempting retail OCTs completely from the UDI rule and "not having" information on such products in the global UDI database "would not be useful".

In its November 2012 comments to the proposed rule, managed care organization Kaiser Permanente said that: "any device capable of producing a measurement or observation value that can inform the care process should be required to be labeled by UDI regardless of its status as a 'retail' or 'OTC' device."

Kaiser added that all devices should be labeled that are ever prescribed or conveyed via a standard electronic prescription transaction; reimbursed by public or private health insurance through standard claims processing; included in other HIPAA transactions; subject to federal requirements for quality measurement, public health reporting, biosurveillance, clinical laboratory reporting, clinical trials data reporting, or other federal/state regulation or guidance; or subject to recall.

Premier, a healthcare alliance serving more than 2,700 hospitals, said that retail products should be subject to UDI requirements but that "their UPC should be deemed to be the UDI for this purpose". "In particular, we believe it is essential that labelers of the affected retail products be required to submit UPC data to the GUDID. Instead of the proposed exemption, we believe that non-prescription devices sold at retail establishments should be required to comply with all UDI-related requirements save for the need to obtain a UDI other than their UPC."

"We are trying to figure out the best way… to address [the concerns]", Mr Crowley said. The FDA, he added, would need to find a solution that is reasonable both in terms of cost burden and the need to be able to identify devices regardless of their prescription or OTC status.

Mr Crowley noted that many OTC devices are Class I (ie low-risk), though there are a few OTC devices that are in higher-risk classes. Class I devices would be subject to the final rule five years after its publication.

"There's a lot of interest in not seeing this [OTC] exemption in the final rule so we're taking this into account," Mr Crowley said. "I want to make those manufacturers of devices that are primarily OTC aware that this exemption might not last in the final rule and these devices might find their way back into UDI."

Other exemptions

There are a number of exemptions in the proposed rule, Mr Crowley noted. Highlighting a few of these, he said that Class I devices would be exempt from the need to include production identifiers, though they will have to bear a device identifier on their label. Class I devices that are currently exempt from good manufacturing practice requirements (ie very low-risk devices) would also be exempt from the UDI rule.

For individual Class I, single-use devices, all of a single version or model, that are distributed together in a single device package, which are not intended for individual sale [eg a box of bandages], the FDA would allow the UDI to be on the package, Mr Crowley said. Such an approach would reduce the cost burden for the manufacturer and achieves a good risk-based approach to identifying these types of devices, he explained.

Combination products and kits

The FDA received a great many comments on the definitions and rules for combination products (ie drug/device, biologic/device or drug/device/biologic) and convenience kits (ie two or more devices packaged together) and the subtleties between the two types of products. "We've been working on this and are trying to bring some clarity to the situation," Mr Crowley said.

The FDA officer noted that a combination product whose primary mode of action is a device would have its own UDI; each device constituent would need its own UDI too. An exception here would be for a "combination product that is physically, chemically or otherwise combined with other parts of the [combination product] such that it is not possible for the device constituent to be used except as part [of] the combination product."

Mr Crowley added that each kit (devices only) would have its own UDI and each device packaged in a convenience kit would also have its own UDI distinct from the kits. An exception here would be a device that is intended for a single use – such a device would not need its own UDI.

Commenting on the many comments the FDA has received on how the UDI rule would apply to in vitro diagnostics kits, Mr Crowley said "there'll be more information forthcoming either as the final rule or some guidance associated with it".

Dealing with date format concerns

The date format that the FDA has proposed for use on labels has caused considerable upset among some stakeholders. The agency received an "enormous amount of comments" on its suggestion to use the US centric format of Month, Day, Year (eg JAN 1, 2012), Mr Crowley said.

For example, US medtech industry association AdvaMed said in its comments that the proposed rule was inconsistent with internationally-recognized standards ISO 8601 and ISO 15223.

Most comments focused on the use of an international standard date format, Mr Crowley said, and the agency is "taking all this into account as we work on the final rule".

Stakeholders are also unhappy at the proposed implementation timeframe for the date format of one year after publication of the final rule; AdvaMed has called for a three-year transition period.

Revised IMDRF guidance due in 2013

Mr Crowley stressed that the FDA is endeavoring to drive a globally harmonized approach to UDI. The agency's proposed rule is based on a UDI guidance document published by the Global Harmonization Task Force in 2011. In addition, the FDA is currently working with the International Medical Device Regulators Forum – which recently superseded the GHTF – to update the original guidance document and both parties hope to publish the revised guidance by the end of this calendar year; UDI is one of a handful of GHTF activities that the IMDRF has chosen to continue to work on.

The updated document is not expected to be "vastly" different from the original guidance, Mr Crowley said. It will, for example, go into some more detail on how UDI would apply to certain device types and contain additional information to drive a globally harmonized approach.

Mr Crowley noted that the European Commission had recently published its interest in developing a UDI system which, he said, "looked very much like [the GHTF]… guidance document".

In keeping with the notion of a globally harmonized approach to UDI, the FDA is looking to accredit global standards development organizations to operate its system for the issuance of UDIs – accredited organizations would be known as issuing agencies. Using a global standards development organization would "facilitate the use of a single identifier anywhere where there is a UDI system in the world", Mr Crowley explained.

The FDA officer said he expected the three global standards development organizations, GS1, HIBCC and ICCBBA, with which the FDA has been working "for many years" to apply to become accredited issuing agencies under the agency's UDI rule. All three organizations meet the standards associated with ISO 15459, Mr Crowley noted, adding that many manufacturers were already using one or more of the organizations. "The goal is that each country would not, as they do in the pharmaceutical space, create their own identifier."

According to the FDA's proposed rule, the manufacturer would develop a UDI according to one of the accredited issuing agencies and apply it to the "base package" as well as to higher levels of packaging to support its use throughout the supply chain.

The default location is the label of the device.

The FDA expects the UDI to be both human readable and encoded in a form of automatic identification technology. The FDA has not advocated any specific technology. "In contrast to, for example, the pharmaceutical barcode rule where FDA requires NDC [national drug code] to be encoded on a linear barcode, we're not identifying any particular technology that can or cannot be used," Mr Crowley said. "Instead, the FDA is relying on standards development organizations and stakeholders to make "intelligent decisions" about which technologies can, should or should not be used for various device types in various environments. "We're a little nervous about this," Mr Crowley admitted, adding that "we do believe it's the right path to take". He said the FDA was hoping to see convergence around a limited number of technologies and did not want to see a proliferation of technologies that various stakeholders would not be able to use. "For example, there are many types of linear barcodes and we don't want to see 15 or 20 different types of barcodes out there."

The proposed rule applies direct part marking requirements – ie where the UDI is placed on the device itself so it can be identified after it is removed from the packaging – to three categories of devices:

  • an implantable device (ie implanted for more than 30 days);

  • devices that are intended to be used more than once and are intended to be sterilized before each use; and

  • stand-alone software that is deemed to be a ''device'' under US law.

AdvaMed said that three-quarters of respondents to a survey said there would be additional costs associated with direct marking equipment purchases, implementation of new processes in manufacturing, validation of changes and standard operating procedure documentation updates and training. These may exceed $125,000 on average per packaging line. Some respondents estimate that direct marking equipment purchasing and installation would cost over $1 million.

GUDID: database to be up and running by June

As for the GUDID, the FDA is hoping to have the publically available database up and running for people to interact with by June, "hopefully in concert with the publication of the final rule". In addition, the agency is working on a draft user guidance that will describe how the database will work; this could be available in March.

Manufacturers will be responsible for submitting UDI data to the GUDID, which will collect basic identifying information such as: device identifier; make/model/clinically relevant size, FDA pre-market authorization number. The database will also contain the FDA listing number, which will not be made publically available.

"There are also administrative attributes that we intend to collect" in the database such as DUNS numbers (which are used by the FDA to identify firms and facilities); FDA product code (procode) and whether the device is for single-use, Mr Crowley said.

The Global Medical Device Nomenclature will be the generic identifier for devices in the database. "Manufacturers will submit GMDN codes to the FDA and we will populate the database with [a] GMDN term and definition for each device," Mr Crowley explained.

The GUDID has "a very robust" interface and there will be a number of different ways for the various users to interact with it and obtain information. For example, a large organization with a lot of UDI records would be able to submit data using the Health Level 7 structure product labeling standard.

Implementation deadlines

As for when the UDI requirements would start to become effective, all Class III devices would have to start complying within a year of publication of the final regulation (see Table 1). Class II implants and life supporting/life-sustaining devices would have two years to comply. Remaining Class II devices would have three years to begin complying and Class I devices five years.

The FDA has allowed more time for the direct part marking requirements in recognition of the burden involved. Except for implants and life-supporting/life-sustaining devices, direct part marking requirements would be effective two years after the class effective date for devices – meaning, for example, that Class I devices that do not fall into the excluded category would have seven years to comply. Implants and life-supporting/life-sustaining devices, regardless of class, would need to bear a direct part marking within two years of the final rule being published.

The FDA had published a list of medical devices – by product code – that it classifies as implantable, life-saving and life-sustaining. Mr Crowley confirmed that the agency is now considering whether devices on this list are appropriate and whether certain devices should be removed or added to the list.

Regarding the likelihood of the agency extending certain of its proposed implementation deadlines in the final rule, as requested by a number of stakeholders, Mr Crowley gave little away6: "We are currently in the process of reviewing all the comments."

Other UDI activities

The FDA is engaged in a number of activities to help support its UDI endeavors. For example, the agency is working with the Brookings Institution to develop a roadmap to help the healthcare system adopt and use UDI effectively. "We hope to have that roadmap out by the end of this calendar year," Mr Crowley said. He added that information and links to "anything and everything we have done" on UDI, can be found on the UDI website (www.fda.gov/UDI) and urged interested parties to sign up to the FDA's email distribution list (cdrhudi@fda.hhs.gov) for alerts of when new information is posted on the website. The fact that nearly 50,000 people have signed up to the list so far reflects industry's interest in the subject.

References

1. FDA, website accessed 25 March 2013, www.fda.gov/UDI

2. RAPS webcast, Unique Device Identification, Transforming the Global Medical Device Landscape, 6 February 2013

3. UDI proposed rule, Federal Register, 10 July 2012, 77(132), http://www.gpo.gov/fdsys/pkg/FR-2012-07-10/pdf/2012-16621.pdf

4. Proposed Rule; Amendment, Federal Register, 19 November 2012, www.federalregister.gov/articles/2012/11/19/2012-28015/unique-device-identification-system

5. SRA passim

6. Personal communication, Jay Crowley, 13 February 2013

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