EMDT_European Medical Device Technology

European Medical Device Technology, Summer 2015

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12 | Summer 2015 European Medical Device Technology emdt.co.uk regulatory How U.S. UDI Requirements Could Affect You Medical device manufacturers that serve the U.S. market need to be up to speed on unique identification system (UDI) requirements as well as other regulations that have been modified as a result of the rule. T he use of bar codes in almost every facet of daily life is ubiquitous, from the grocery store to airline board- ing passes. And while a bar code system for tracing pharmaceutical products has been in use for many years, the medical device sector finally joined the universal range of items to facilitate traceability of critically important products in 2013 upon FDA's release of the UDI Final Rule. The UDI program is intended to reduce medical errors that result from misidentification of a device or confusion concern- ing its appropriate use; lead to more accurate reporting of adverse events by making it easier to identify the device before submit- ting a report; and enable FDA, health pro- viders, and industry to more rapidly obtain useful information from adverse event reports, locate the particular device concerned and thus gain a better understanding of the underlying problems. UDI System Requirements FDA requires a UDI on every device label and package, except where the rule provides for an exception or alternative placement. For example, under 21 CFR 801.30, Class I devices exempted by FDA from the good manufacturing practice requirements of 21 CFR 820 and investigational devices are exempt from UDI requirements. Each UDI must be provided in a plain-text version and a form that uses automatic identification and data capture (AIDC) technology. The UDI must also be directly marked on a device that is intended for more than one use and intended to be reprocessed before each use. The rule also requires the submis- sion of information on each device to FDA's new Global Unique Device Identification Database (GUDID). A UDI will typically include both a device identifier (DI) and a production identifier (PI); however, the UDI of a Class I (non-exempt) device is not required to include a PI. The DI is a mandatory, fixed portion of the UDI that identifies the labeler— generally the manufacturer—and the specific model or ver- sion of the device. Used to identify only one device version or model, the DI is used as a reference to find information about the product in the GUDID. However, the labeler must assign a new DI if a change is made to the device such that it becomes a new version or model. If a device version or model is discontinued, the DI cannot be reas- signed to another device. In contrast to the DI, the PI is a conditional, variable portion of the UDI. If a labeler has included information such as the lot or batch within which a device was manufactured, the serial number of a specific device, the expiration date of a specific device, or the date a specific device was manufactured, that informa- tion must be included in the PI portion of the UDI. Labelers can obtain the DI portion of the UDI for each device or model from an FDA-authorized agency. As of April 2015, three agencies have been authorized to operate on the GUDID; the list of authorized agencies is available on the FDA website. The public can search and download infor- mation from AccessGUDID. UDI Implementation Timeline It is important to note that the UDI system was designed to go into effect in stages over a period of seven years. This staggered approach is intended to ensure a smooth implementation and to spread out the costs and burdens of implementation, rather than having to be absorbed all at once. Class III devices and devices licensed under the U.S. Public Health Service Act (namely, human cells, tissues, or cellular or tissue-based products regulated as a device), had to comply with Maria Donawa

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