In summary, for European manufacturers of medical devices, the US market is usually the first international destination after the European single market. Successfully entering the US market is considered a strategically important milestone and a gateway to further international markets. In the US market, medical devices are legally subject to the Federal Food, Drug, and Cosmetic Act (FD&C Act). These legal requirements, which are overseen by the FDA, are legally binding and can be found for medical devices in Title 21 of the Code of Federal Regulations, specifically in CFR Title 21 – Food and Drugs: Parts 800 to 1299.
As in the European market, the FDA also provides precise definitions of what constitutes a medical device. The intended use is the key question here. If it is clearly a medical device under US law, the device must be classified into one of the three FDA classes (Class I, II, III). This classification is not carried out by the FDA itself, but is the responsibility of the medical device manufacturer. While the classes are defined similarly to those in Europe, there is no guarantee that a product will fall into the same class.
Depending on the classification, medical devices must go through procedures of varying complexity before they can be approved for the US market. These and other tasks relating to the introduction of medical devices to the US market must be successfully managed.
Our offer:
We define the tasks together and, if desired, provide the appropriate solutions. We have experience with FDA requirements and would be happy to support you in successfully positioning your products in the US market.
If you need support with FDA approval, we are happy to help!
