pick, gloves, toothbrush) Class II (eg, dental fillings, ceramics, drills) Class III (eg, stent, implantable pacemaker) Criteria FDA Requirements Minimal health and safety risks, established precedent Need to register with FDA but not get approval before putting it on the market Presents safety and health risks that aren't completely controlled by GMP (good manufacturing processes) Submit 510-K application to FDA, include detail about device, marketing materials, device safety features, and other paperwork Invasive, inflammable, or presents other significant significant safety risks. Often times a new type of device Very thorough process similar to drug approval. Requires clinical trails and mountains of paperwork