Glossary
Premarket Approval (PMA)
What is PMA?
Premarket Approval (PMA) is a scientific and regulatory review process that the FDA uses to evaluate the safety and effectiveness of Class III medical devices. These medical devices are considered to be high-risk devices that are life-sustaining, life-supporting, or implanted in the body.
What are the key aspects of PMA?
- Class III Devices: PMA is required for Class III medical devices, which are considered to be high-risk devices, such as pacemakers, implantable cardioverter-defibrillators, and artificial joints
- Scientific and Regulatory Review: The FDA conducts a thorough review of the device’s safety and effectiveness, including clinical trials, bench testing, and other scientific data.
- Approval: If the FDA approves the PMA, the device can be marketed and sold in the United States.
- Post-Approval Requirements: Manufacturers must comply with post-approval requirements, such as reporting adverse events and conducting post-market surveillance.
How does PMA help in pharma?
Premarket approval (PMA) is a critical process for Class III medical devices, requiring rigorous FDA evaluation to ensure safety and effectiveness. This involves a comprehensive scientific and regulatory review, where manufacturers must provide valid scientific evidence, including clinical trial results and nonclinical testing data. The PMA process assures device quality, enhances consumer confidence, and limits legal challenges due to preemption for FDA-approved products. Successful PMA applications provide a competitive advantage, allowing companies to market their devices while ensuring compliance, ultimately contributing to improved patient safety and health outcomes.
