8 Apr /14


FDA UDI recallOn Monday, Mazda recalled 40,000+ vehicles of their Mazda6 line because of an apparent fire hazard that is linked to yellow sac spiders. This is, in fact, the second recall related to the hydrocarbon hungry spiders that are apparently attracted to the gasoline odors and therefore weave their webs in the car’s fuel tank which, in turn, prevents proper airflow. In 2011, Mazda already had to recall 52,000 sedans of their 6 series due to reported cracks in the fuel tank caused by the spider webs.

Recalls are a manufacturer’s nightmare, regardless of the industry you are doing business in. They damage a company’s reputation, tarnish its public profile with negative publicity, and create immense additional costs. Perhaps no other industry, however, has to be as prepared for a possible recall than the pharmaceutical industry, as a product recall through the FDA might be synonymous with the end of the product itself. In an effort to be able to identify medical and pharmaceutical products quickly and effectively in case of a recall, the Food and Drug Administration recently passed new legislation mandating the implementation of the so-called Unique Device Identification for all products. The UDI is a specific, standardized labeling that is meant to ease the identification of products and to help manufacturers of medical products to protect their supply chain.

The labeling and localization of pharmaceutical and medical products has always been subject to strict country-specific guidelines and the implementation of UDI labels is no exception. The new machine-readable UDI product specifications have to be designed in accordance with FDA regulations and subsequently submitted to the Global Unique Device Identification Database where all product data for products licensed in the U.S. is stored.

Especially for medical and pharmaceutical companies from outside the U.S., this process can be time-and cost- consuming. Our experience shows, that one of the most common pitfalls when it comes to UDI compliance is the fact that producers simply underestimate the complexity of the process and as a result are faced with immense time-pressure and even delayed product launches. The key aspect to keep in mind when planning and budgeting for the UDI phase of a new product is that the process involves not only different departments of your own company (production, compliance, and marketing) but also external distributors, printers, and other suppliers. It is the successful coordination of these puzzle pieces that results in a headache free UDI implementation.

EVS Translations can help you with the process and offer the solutions you are looking for. We have over 20 years of experience aiding our corporate partners from Germany, Israel, France, Italy, England, Russia, Korea, Japan, the U.S. and other countries to introduce their products to new markets and meet local regulations.
Contact us today to discuss your projects: +1 404-523-5560 or send us an email: quoteusa(at)evs-translations.com.