Medical Devices

Determine if your product meets the Definition of a medical device. If it does, there are FDA requirements that apply. First, see the definition below. Medical Device Definition Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers with micro-chip technology and laser surgical devices. In addition, medical devices include in vitro […]

The US FDA regulates all medical devices marketed in the US, which are grouped into three broad classes. Any medical device approved by the FDA is classified as either Class I, II, or III depending on the device’s risk, invasiveness, and impact on the patient’s overall health. But where are the lines drawn between each of these three classes, and why?