Based on your responses, your product likely falls under the PMA pathway, and is most likely a Class III. This pathway is required for Class III, high-risk, or life-sustaining devices. It involves the most rigorous FDA review process and typically requires extensive data, including clinical evidence, to demonstrate safety and effectiveness. You will likely need a full clinical trial to support this market application.
Class III devices present the highest potential risk and typically support or sustain human life. They require full regulatory review and ongoing post-market controls.
PMA devices almost always require a clinical trial (IDE study) as part of the submission process. Clinical data is essential for FDA approval.
Schedule a free discovery call with our team to clarify your path and avoid costly missteps. We will walk through the specific requirements and help you build a confident submission strategy.
