The Regulatory Pathway to Market Class III Surgical Medical Devices in the United States

The United States (US) Food and Drug Administration (FDA) regulates the safety and effectiveness of drugs, biologics, and devices. Medical devices are classified as Class I, Class II or Class III devices in the United States. Class III devices are highrisk and are subject to rigorous pre-market approval (PMA) requirements to demonstrate that the product is safe and effective for its intended use before being sold. Pre-market novel, significant risk Class III (surgical) medical device require an investigational device exemption (IDE) to permit the collection of safety and efficacy data via clinical trial to support the PMA. Pivotal studies can be used for market approval of therapeutic devices. All of these devices may have different levels of complexity, require user skill and training, involve a learning curve, and are numerous type devices. Time, cost considerations, and regulatory oversight must be planned within the clinical trial and add to the overall go-to-to market timeline. Study design, execution, and analysis are reviewed.