Postmarketing surveillance

Postmarketing surveillance


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.[1] 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.[2] 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[4] or through a 522 Postmarket Surveillance Study.[3]


  1. 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.
  2. "Post-marketing Surveillance". U.S. FDA/CDER. 2004.
  3. "522 Postmarket Surveillance Studies". U.S. FDA/CDRH. 2014.