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What is Premarket Approval?

The U.S. Food and Drug Administration (FDA) uses a process called premarket approval (PMA) to evaluate the safety and effectiveness of Class III medical devices. These devices are critical in preserving or prolonging human life, significantly contribute to preventing impairment of human health, or carry a potential risk of illness or injury that is unreasonable.

Because of the high level of risk associated with Class III medical devices, the PMA pathway is the most rigorous approval process for medical devices by the FDA. The PMA process involves a comprehensive scientific and regulatory review of the medical device. The applicant must provide valid scientific evidence to demonstrate the device’s safety and effectiveness for its intended use(s). The FDA will then review the data submitted by the applicant, which may include clinical trial results, nonclinical testing data, and manufacturing information.

Once the FDA approves the PMA application, the device can be marketed for its intended use(s). It’s important to note that the PMA process is the most rigorous and time-consuming regulatory pathway for medical devices by the FDA. It typically takes several years for a medical device to complete the PMA process and receive FDA approval.