The U.S. Food and Drug Administration approves high-risk class III medical devices after the device owner submits a premarket approval application and FDA personnel review it, reports the FDA. The FDA clears class II lower-risk devices after manufacturers prove that they are substantially equal to similar devices already on the market. Low-risk class I devices do not need FDA clearance or approval.
High-risk class III devices include heart valves and pacemakers, notes ABC News. They are of substantial importance in sustaining life and carry a significant risk of injury or illness, explains the FDA. A premarket approval constitutes a private license to sell the device. The individual or company that owns the device submits information and research data proving the device's safety, and the FDA generally takes more than 180 days to review the application and make its determination to approve or deny it. After the determination, the FDA places a public posting on the Internet for 30 days, along with the data involved in the decision, inviting interested people to petition for reconsideration.
The FDA does not consider class II medical devices, such as exercise equipment and X-ray machines, to be life-threatening, so manufacturers can avoid the lengthy process of premarket approval by having the FDA clear instead of approve them, according to Medical News Today. Class I low-risk devices include gauze and stethoscopes. Although the devices do not need approval, the manufacturers must correctly label, package and register them, cautions the FDA.