What is the purpose of the SMDA?

The purpose of the SMDA, or Safe Medical Devices Act, focuses on the importance of monitoring the safety and effectiveness of medical devices in the healthcare system. Specifically, it mandates the reporting of serious injuries or deaths that may be caused by medical devices. This requirement is crucial as it enables the FDA to monitor potential safety issues and take necessary actions to protect public health.

By enforcing this reporting mechanism, the SMDA helps ensure that any adverse events related to medical devices are documented and analyzed. This process is vital for identifying patterns or emerging problems with specific devices, which can lead to improved safety regulations and better design of medical equipment. Continuous oversight can ultimately enhance patient safety and protect against future incidents that may arise from device usage.

The other options do not align with the primary focus of the SMDA, as they pertain to different aspects of healthcare regulation and patient protection that are covered by other laws or organizations.