The premarket approval (PMA) process is the most stringent pathway for getting a medical device approved for marketing and sale in the United States. Unlike the 510(k) process, which focuses on demonstrating substantial equivalence, the PMA process requires manufacturers to provide comprehensive scientific evidence to show the safety and effectiveness of their devices.
The PMA process is reserved for high-risk medical devices that are new, innovative or have no substantially equivalent predicate device on the market. Devices requiring a PMA include implantable pacemakers, artificial heart valves, and specific diagnostic imaging devices.
To initiate the PMA process, the manufacturer must submit an extensive application to the FDA, including detailed information on the device's design, manufacturing processes, preclinical and clinical data, and proposed labeling. The application must demonstrate that the device is safe and effective for its intended use and provide evidence of its performance and benefits.
The FDA reviews the PMA application in-depth, considering the scientific evidence provided, and determines whether the device meets the required standards for safety and effectiveness. This rigorous review process can take several months or even years, depending on the complexity of the device and the amount of data submitted.
If the FDA approves the PMA application, the device can be marketed and sold in the United States. However, it's important to note that the approval is specific to the device and its intended use, and any changes to the device's design or labeling may require additional support.