The market for in-vitro diagnostics in the USA will increase between 2011 and 2016 from 18.4 bn. to 24.7 bn. US$ pursuant to the market research bureau Freedonia Group. The demand of clinical-chemical products will, primarily due to the usage of patient screening as well as the self-monitoring of diabetes patients in combination with an increasing amount of available Point-of-Care-Systems.
As per US Food and Drug Administration (FDA) in-vitro diagnostics are considered medical devices, whereas according to the Federal Food, Drug and Cosmetic Act they also can be contemplated as combination products. With regard to the regulatory topics in-vitro diagnostics do underlie the pre- and post-market control of the FDA like other medical devices.
PROSYSTEM AG assists you identifying the regulatory requirements for a successful market authorization of your product. Whether pure in-vitro diagnostic or combination product, we accompany you with our long-term expertise of the US American market.