Questions
1. What is the procedure for the approval of a medical device? The FDA's Centre for Devices and Radiological Health executes this mandate. They have the final say on who manufactures, repackages or imports medical devices for use in the US. The medical devices are grouped in classes: I. II and III. These classes depend on the need for controls, exemptions and premarket approval. There is an increasing severity of the regulation procedure from class I to Class III (FDA, September 2014). The following are steps that are followed in the registration and regulation procedure. First, the sponsor (manufacturer ...
