Through its premarket review process, the FDA makes every effort to assure that risks associated with medical devices have been minimized when those devices first enter the market. However, once medical devices are widely used by health care providers and patients, new issues occasionally arise.
Postmarket surveillance is a collection of processes and activities the FDA uses to monitor the safety and effectiveness of medical devices once they are on the market. These activities are designed to generate information to quickly identify poorly performing devices and other safety problems, accurately characterize real-world device performance and clinical outcomes, and facilitate the development of new devices, or new uses for existing devices.
Strengthening Our National System for Medical Device Postmarket Surveillance: Update and Next Steps - April 2013(PDF - 289KB)
- National Medical Device Postmarket Surveillance Plan - September 2012
High-Tech Methods to Monitor High-Tech Devices Strengthening Patient Care: Building a National Postmarket Medical Device Surveillance System(PDF - 1.2MB)