In a highly anticipated move, the US Food and Drug Administration (FDA) has announced the final release of the Unique Device Identification (UDI) rule, reflecting a number of changes called for by industry.
A UDI is, as its name implies, a system of identifying each medical device using a specific system.
The system has a number of allures for regulators. "The unique device identification system will help reduce medical errors, and will allow FDA, the healthcare community, and industry to more rapidly review and assess adverse event reports, identify problems relating to a particular device, and thereby allow for more rapid and effective corrective actions that focus sharply on the specific devices that are of concern," FDA wrote in 2012.
At its core, the rule calls for devices to be marked with a UDI system composed of two parts: a device identifier that corresponds with the type of device and its manufacturer, and a production identifier that states its lot, batch, serial number, expiration date, date of manufacture and other relevant information.
The rule was originally mandated by the FDA Amendments Act (FDAAA) of 2007, but was subject to lengthy delays, both due to extensive rewrites resulting from industry criticism and months of review by the Office of Management and Budget (OMB).
Another reason for the delay: regulators wanted to harmonize the rule to the extent possible with international regulations being generated by the International Medical Device Regulator's Forum (IMDRF), the successor group to the Global Harmonization Task Force (GHTF).
In July 2013, FDA released a draft version of the rule which called for, among other things, a standardized, alpha-numeric system of identifying elements to be contained within an FDA-run database. The FDA Safety and Innovation Act (FDASIA) of 2012 later set a statutory date by which the rule was supposed to have been released -31 July 2013-but the date came and went with no release of the rule by OMB.
See also: Regulatory Focus' Extensive Interview With Jay Crowley, FDA's Lead on the UDI Rule.
Many Changes Made to Draft Rule
Now FDA is out with the final rule, which reflects an extensive number of changes called for by industry in its 270 submissions and 1,700 pages of comments.
The basics of the rule remain the same: Devices that are intended to be used more than once must bear direct markings on the device itself, and the identifying mark must be submitted to the Global Unique Device Identification Database (GUDID) in plain text format. Reprocessed devices will be subject to the same requirement. Single-use devices (SUDs) will not.
However, the rule includes several major concessions to industry as well. Most notably: Implants will not be required to bear direct markings. Some in industry were concerned with this requirement, noting it introduced potential efficacy and safety problems, and would be difficult to comply with in cases where an implant was extremely small.
Another major change is with respect to the date format. FDA was originally pushing for a US-centric date system of Month/Day/Year. This would have caused problems with global systems, however, which use a Year/Month/Day system per the standards (8601) of the International Standards Organization (ISO). As anticipated by Crowley in April 2013, FDA conceded this point, and will now follow the ISO standard. This will allow its GUDID database to be linked more easily with those maintained by other regulators.
A third issue noted by Crowley in April 2013 that the revised UDI rule reflects is related to existing inventory. Manufacturers had questioned whether FDA would require them to immediately mark existing products, which could cost them substantial sums to reprocess. The rule will specifically exempt inventory devices "for an additional three years, during which time these devices can remain on the market without having to comply with UDI requirements," FDA writes in the notice.
FDA also said that it would in some cases grant an additional year for high-risk Class III medical devices to become compliant with the UDI provisions, giving them a total of two years after the final issuance of the rule if the agency believes the additional time could prevent shortages from occurring. "For example, if the sole labeler of a particular class III device provides information showing that it will not be able to comply with UDI labeling requirements within the 1-year timeframe, and showing that a medical device shortage will result if it is unable to continue to ship the device until such time as it can comply with UDI labeling requirements, FDA would consider an extension of the 1-year compliance date," FDA wrote.
All other manufacturers will have 90 days to begin complying with the UDI rule as of Monday, 23 August 2013, FDA said.
Another major change is a clarification that stand-alone software regulated as a medical device will have to meet UDI requirements. However, unlike most devices, software will only have to exhibit a means of displaying the UDI. While this can be on the package, it can also be within the software itself-a major concession that allows companies that don't sell a physical product (i.e. their product is downloaded) to meet UDI requirements. See Section 801.50 of the rule for additional details.
Another major exemption will be given to Class I medical device labeled with a Universal Product Code (UPC). FDA said a UPC marking would serve as a UDI in these cases.
Another change reflects FDA"s opinion that combination product will not need to have the device bear a separate UDI from the combination product as a whole (e.g. a pre-filled syringe would have a cohesive UDI; the syringe itself would not have its own unique UDI).
- Devices packaged into a convenience kit do not need to be directly marked with a UDI provided that the convenience kit is marked by the UDI.
- The rule clarifies that a device does not need to be marked with a UDI if it already bears a National Drug Code (NDC) marking. Some exceptions to this rule exist per Section 3.2(e)(1).
- All NDCs and NHRIC identifiers currently assigned to devices will be rescinded by 24 September 2018 and replaced with a UDI.
- A new section of the rule outlines when changes will require the use of a new device identifier
- Information will need to be submitted to the GUDID on whether a device may be safely used with a MRI machine
- FDA may request changes be made to a GUDID submission if it "appears to be incorrect." The labeler then has 10 days to either make changes or explain why it is correct. FDA may then "delete or replace" the information if it so chooses.
The entire rule is online on the Office of the Federal Register's website.