The U.S. Food and Drug Administration FDA Certificatiion process oversees the certification of medical devices to ensure their safety, effectiveness, and quality before they enter the market. The process depends on the device's risk classification, which ranges from Class I (low risk) to Class III (high risk).
For Class I devices, most are exempt from premarket approval but must comply with general controls. Class II devices typically require a 510(k) Premarket Notification, demonstrating substantial equivalence to a legally marketed device. Class III devices, representing the highest risk, often need Premarket Approval (PMA), requiring extensive clinical data and scientific evidence to support safety and effectiveness.
Manufacturers must also adhere to the FDA’s Quality System Regulation (QSR) for design, production, and post-market activities. Once approved, devices must undergo ongoing monitoring and reporting of adverse events. The FDA certification ensures public confidence and compliance with U.S. healthcare standards.
