ABSTRACT

The current healthcare infrastructure is built upon medical devices. All aspects of their manufacture, advertisement, and utilization need to be controlled considering their importance in the daily practice of medicine. Higher dependability performance of the medical device can lead to higher reliability of diagnosis treatments and diagnosis when evidence-based conformance assessment of medical device during PMS is standardized and relies on traceability of medical device measurements. The Food and Drug Administration (FDA) is in charge of regulating PMS-related activities, which include mandated reporting platforms like Medical Device Monitoring (MDR) and as cutting-edge instruments that improve PMS performance by gathering and analyzing actual data. The contribution of post-approval studies (PAS) and post-market clinical follow-up (PMCF) studies to the generation of extra safety and performance data is also examined in this article. Important issues are covered, such as data quality, reporting compliance, and integrating emerging technologies like machine learning and artificial intelligence into PMS. The purpose of this review is to give readers a thorough overview of the PMS framework that is currently in place in the United States, emphasizing its advantages, disadvantages, and potential improvements for medical device safety and monitoring. Keywords: Medical Devices, Post-Market Surveillance (PMS), Food and Drug Administration (FDA), Medical Device Reporting (MDR), Data Quality, Reporting Compliance, Regulatory Compliance, post-approval studies (PAS), post-market clinical follow-up (PMCF)
Publication date: 01/11/2025

https://ijbpas.com/pdf/2025/November/MS_IJBPAS_2025_9570.pdf

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https://doi.org/10.31032/IJBPAS/2025/14.11.9570