Premarket approval is the process of scientific and regulatory review of the safety and effectiveness of Class III medical devices; it is the most rigorous premarket device submission that FDA requires. Class III devices include those that support or sustain human life, are important to prevent impairment of human health, or present a potential, unreasonable risk of illness or injury.
Premarket
A premarket notification, or 510(k) submission, is the mechanism through which the majority of medical devices obtain U.S. marketing clearance. A 510(k) submission is required for any device intended for human use unless the device is exempt by regulation (most Class I and select Class II devices) or is a Class III device.
FDA is responsible for assuring the safety and effectiveness of medical devices in the United States and regulates these products using a three-tiered, risk-based classification system:
An investigational device exemption (IDE) allows a medical device that has not received marketing clearance or approval to be shipped for use in a clinical study without complying with other regulations of the Federal Food, Drug and Cosmetic Act. All investigational devices fall under one of the following categories:
FDA’s Center for Devices and Radiological Health (CDRH) has five standing advisory committees, which provide independent professional and technical expertise on the development, safety and effectiveness, and regulation of medical devices and electronic products that produce radiation. These committees are: the Device Good Manufacturing Practice Advisory Committee, the National Mammography Quality Assurance Advisory Committee, the Technical Electronic Product Radiation Safety Standards Committee, the Patient Engagement Advisory Committee and the Medical Devices Advisory Committee.