There is cultural debate surrounding the regulation of medical devices in the USA. In a recent article, a team of researchers compare regulations between the US system and the European Union.
Both the USA and Europe have policies on regulating Implanted Medical Devices but there there needs to be a balance between patient safety and good business. These two forces naturally create a vacuum for corruption to occur.
There are three classes of medical devices:
Class 1. Low risk (Stethoscope)
Class 2. Medium Risk, which can rely on comparisons to previously cleared medical devices. As long as the company can make a strong argument that the device is similar to previously cleared devices, they can get an approval.
Class 3. Higher Risk devices such as implantable medical devices need a more complicated approval process, however there are tons of loopholes.
They conclude their analysis with this statement:
Systems for approving new medical devices must provide pathways to market for important inno- vations while also ensuring that patients are ad- equately protected. To achieve these goals, the United States and European Union use a combi- nation of premarket testing and postmarket vig- ilance but with some marked contrasts in their approaches.
You can access the medical device database which is operated by the Food and Drug Administration: Manufacturer and User Facility Device Experience.
