Navigating PMS and Reporting for Medical Devices: Understanding the US FDA’s Requirements and Best Practices
The realm of medical devices is one of constant innovation and advancement. However, the journey of a medical device does not end with its entry into the market. Post-market Surveillance (PMS) and reporting are critical components of a device’s lifecycle, which ensure ongoing safety and efficacy for end-users. To address this, the United States Food and Drug Administration (US FDA) has established stringent PMS requirements to protect public health.