What is the main purpose of Post Marketing Surveillance (PMS)?

The main purpose of Post Marketing Surveillance (PMS) is to monitor the safety of approved medical products. This phase occurs after a product has been made available on the market, where it is crucial to gather and analyze data related to adverse events, side effects, and overall product performance in the real-world setting. The goal is to ensure ongoing safety and efficacy assessments beyond the controlled environment of clinical trials. This monitoring can lead to important regulatory actions, such as label changes, restrictions, or even product recalls if significant safety issues are identified.

PMS plays a significant role in understanding how a medical product performs when used by a broader population outside of clinical study participants, and it helps regulatory bodies, such as the FDA, to protect public health by identifying any potential risks associated with products that were previously deemed safe during pre-market evaluations.