Over the years, it has been amazing to see how Europeans seem to get all the really cool new hearing products first. One product after another has been approved for CE marking (approval for sale in the European Union) long before they were available in the United States. For example, the Envoy was CE Marked in August of 2006 and just approved by the Food and Drug Administration (FDA) for sale in the United States in March of 2010; the Otologics device was approved for sale 
in Europe in October of 2006 but is still awaiting FDA approval for sale in the USA.
Other products, such as new applications for the Symphonics device, are now used to treat hearing loss in Europe, but manufacturers obviously have not yet decided to work toward the difficult process of FDA approval for sale in the US.
The next series of articles at Hearing International examines why the United States and those countries that follow our product development system seem to be the last on the list to obtain newest generation products, when we are arguably the largest developed market on the planet.
Why do we get the good stuff last? Why does it sometimes take years longer to get a product approved for sale in the United States than in Europe? The answers to these and other questions about product development lie in the fact that there are some major differences in the American and the European product development systems. Both insure public safety for food, drugs, cosmetics, medical devices and other products, but they go about the process differently.
Like it or not, the US Food and Drug Administration (FDA) is the agency that controls many product offerings to Americans as well as to citizens of the many other countries that will not allow the sale of certain foods, drugs or medical devices (such as hearing instruments, audiometric equipment, implantable hearing devices) unless they have been approved for sale in the United States.
In Europe and in other countries that follow the CE marking system, of course, there is a whole different process to insure that food, drugs, cosmetics, medical devices, and other products are safe and ready for the marketplace. It is well known in the hearing industry that companies manufacturing new and 
innovative products go to great lengths to obtain CE marking for their devices so that these products can go into production and sale in Europe and other countries that accept CE marking first and later on work their way through the FDA approval process. This allows manufacturers to sell their products in Europe, thus generating income to stay in business while they work their way through the grueling task of obtaining permission to sell their product in the United States and countries that adhere to the FDA development system.
What ARE the differences in these systems? Does the FDA process lead to a safer product? Is it overkill? Would we be better off with a European-style system? To answer these questions we must review the systems and conduct a sort of compare and constrast exercise.
Who is the FDA?
By its own definition (FDA, 2011), The Food and Drug Administration is an agency within the U.S. Department of Health and Human Services. The FDA is responsible for protecting the public health by assuring th
e safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics and products that emit radiation, and by regulating the manufacture, marketing, and distribution of tobacco products.
The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods, and to reduce tobacco use to improve health.
Although certain medications and foods are important to all of us, for our purposes at Hearing International and as audiologists we are most interested in medical devices area.
What is a CE Mark?
CE marking is a symbol that is the abbreviation of the French phrase “Conformité Européenne,” or, in English, “European Conformity.” The initial term for it was the “EC Mark.” This was officially replaced by 1993 European legislation that now designates “CE Marking” as the standard. “CE Marking” is defined as a written statement and is a declaration prepared by the manufacturer to demonstrate the fulfilment of the EU requirements relating to a particular product that will bear the CE mark. According to CE Mark (2011), this declaration documentation must cover one or more products manufactured and be clearly identified by means of product name, product code or other unambiguous reference. These records must be kept by the manufacturer, or his European Authorized Representative if the manufacturer is based outside the European Union. CE Marking is recognized by many countries as the standard for safety and benefit of medical devices.
Next week we will look at how these agencies scrutinize and evaluate medical devices -RMT-
References:
Food and Drug Administration Website (2011). https://www.fda.gov/AboutFDA/CentersOffices/default.htm
CE Mark (2011). How do I get CE Mark and what does it mean. CE Marking.org: Retrieved from the World Wide Web August 27, 2011: https://www.ce-marking.com/what-is-CE-marking.html
Emergo Group (2011). Sections and format of a 510(k) proposal. Retrieved from the World Wide Web August 30, 2011: https://www.fda510k.com/510k-sections-and-format
