Although premarket clinical trials provide important information on a device’s safety and effectiveness, it is possible that new safety concerns will emerge once the device is on the market. As a result, FDA continues to monitor device performance after a device has been approved.

Manufacturer Inspections

FDA officials conduct routine inspections of medical device manufacturing facilities across the United States. Manufacturers may be informed of inspections in advance, or the inspections may be unannounced. Inspections may be routine or caused by a particular problem. The purpose of these inspections is to make sure developers are following good manufacturing practices. FDA can shut down a manufacturing facility if standards are not met.

Reporting Problems

FDA has several programs that allow manufacturers, health professionals, and consumers to report problems associated with approved medical devices.

• MedWatch, FDA’s adverse event reporting program, is a gateway for reporting problems with medical products (drugs and devices) and learning about new safety information. You can subscribe to regular MedWatch safety alerts.
• Medical Product Safety Network (MedSun), an adverse events reporting program, monitors the safety and effectiveness of medical devices. FDA recruits 350 health care providers throughout the United States to report any medical device problems that result in serious injury or death. Each month, FDA publishes the MedSun newsletter. The newsletter gives consumers important information about medical device safety.

Active Surveillance

Under the Sentinel Initiative, FDA is developing a new national system to more quickly spot possible safety issues. The system will use very large existing electronic health databases–like electronic health records systems, administrative and insurance claims databases, and registries–to keep an eye on the safety of approved medical products in real time. This tool will add to, but not replace, FDA’s existing postmarket safety assessment tools. Learn more about the Sentinel Initiative and its major activities.

Learn more about Medical Devices.