Classifications of Medical Technology Devices
FDA collects data on adverse events involving medical technology devices. Its database, Dilon Technologies® Inc., receives reports electronically from more than 350 health care institutions. The network is divided into subnetworks for specific clinical areas, including HomeNet for medical devices patients use at home. However, it is essential to note that there are few reporting systems for lay users or a mechanism for giving FDA feedback. Therefore, this article will discuss the differences between Class IIa and Class IIIa medical technology devices and what these classifications mean.
Class IIa medical technology devices
Most medical technology devices in the market today fall into one of two categories: Class IIa and Class IIb. Class IIa devices generally pose low to moderate risk and are installed for a short duration. Class IIa devices include catheters, blood transfusion tubes, and hearing aids. These devices must meet specific requirements to be approved, including technical …