Postmarketing surveillance (PMS) (also post market surveillance) is the practice of monitoring the safety of a medical device by the OEM after it has been released on the market. Postmarketing surveillance uses a number of approaches to monitor the safety of medical devices, including reporting databases, event monitoring, electronic health records, patient registries and record linkage between health databases. These safety data records are reviewed to highlight potential safety concerns in a process known as data mining.
In the United States, Postmarketing surveillance is overseen by the Food and Drug Administration (FDA), which operates a system of passive surveillance called MedWatch, to which doctors or the general public can voluntarily report adverse reactions to drugs. FDA also conducts active surveillance of certain regulated products. For example, FDA may monitor safety and effectiveness of medical devices through either a Post-Approval Study or through a 522 Postmarket Surveillance Study.
- ↑ McNeil JJ, Piccenna L, Ronaldson K et al. (2010). "The Value of Patient-Centred Registries in Phase IV Drug Surveillance". Pharm Med 24 (5): 281–288. doi:10.1007/bf03256826.
- ↑ "Post-marketing Surveillance". U.S. FDA/CDER. 2004.
- ↑ "522 Postmarket Surveillance Studies". U.S. FDA/CDRH. 2014.