21 Nov/13

FDA and English

FDA translation standardsIt is a well-known fact that the United States far outspends every other developed nation in per capita healthcare. On average, an estimated $8,500 is spent each year on every single one of America’s 300 million citizens: a truly staggering number – and a truly lucrative market. Accordingly, the world’s largest market for pharmaceuticals and medical technology attracts foreign companies like few other sectors. The FDA (U.S. Food and Drug) estimates the following:

  • Products regulated by the FDA originate from 150 different countries
  • 40% of drugs on the U.S. market originate from foreign sources, as do 80% of all active ingredient manufacturers
  • Approximately half of all medical devices used in U.S. hospitals are imported

Even the casual observer of the healthcare market will notice that these numbers offer intriguing insights into the make-up of the U.S. health industry. Yet, although there are many foreign players offering their products to U.S. consumers and institutions prior to market access with their product or procedure, the FDA requires in English a complex myriad of testing and documentation in order to even consider an application to sell in the United States. Initially, the product or technology needs to be subject to multiple clinical tests with well-documented results. Following this, the company needs to demonstrate that best practices and procedures will be used in the manufacturing of the drug/device. Finally, the company needs to consider the label of the product, addressing product information, proper usage, and potential risks and/or side effects.

Once a company has successfully submitted an application and attained market access, testing remains mandatory and bi-annual audits ensure compliance to U.S. standards of production. As a result of these stringent regulations, the FDA currently conducts over 41,000 inspections yearly. In order to lessen the strain, the FDA has started allowing businesses to self-regulate and perform their own internal audits, provided that they strictly conform to or exceed the existing FDA requirements.

Clearly, the healthcare industry in the United States has grown into a truly global undertaking that can present great opportunities for foreign companies. However, this opportunity can easily be complicated for a foreign company that operates in a language other than English. A misunderstanding of the English FDA requirements can easily result in the invalidation of clinical results and the revoking of production rights. Moreover, a slight mistranslation of a manufacturing process or an omitted word on the product label could potentially delay or even void a product application. In order to assure that a company can clearly and precisely define and describe its product in any language, it is advisable to seek and utilize the services of a professional and experienced translation company that can meet the needs of business in an industry where language and wording are critical.

EVS Translations works alongside major medical companies, medical device manufacturers, and associations in the U.S. and in other markets. Our medical translators have a sound understanding of key medical terminology and abbreviations, and are familiar with all FDA regulations.

EVS Translations provides FDA-compliant content and produces required formats for all U.S. medical labeling texts, such as medical device user manuals, full prescribing information (FPI), patient information leaflets (PILs), preclinical and clinical trials, summary of product characteristics (SmPCs), and similar documentation.
Contact us as soon as you plan to start your FDA submissions and we will help your business comply with FDA standards.

Call us today at +1 404-523-5560 or send us an email: quoteusa(at)evs-translations.com.