Medical device post market surveillance: Updates and trends

Post-market surveillance (PMS) is a critical part of pharmacovigilance, the science that focuses on the detection, evaluation, monitoring, and prevention of the unwanted effects of pharmaceutical products. It is vital in ensuring the safety and effectiveness of medical devices. With the crucial role PMS plays in the healthcare industry, it merits the attention of patients, device manufacturers, and regulators. There have been developments involving or affecting post-market surveillance that needs to be highlighted because of their far-reaching consequences. Expanded authority of the US FDA The passing of the 2023 Omnibus Bill marked the expansion of the authority of the United… [Continue Reading]