The 522 Postmarket Surveillance Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated under section 522 of the Federal Food, Drug and Cosmetic Act. The program helps ensure that well-designed 522 postmarket surveillance studies are conducted effectively and efficiently and in the least burdensome manner.
The possible reasons that the FDA requires 522 postmarket surveillance studies include:
- 1. The FDA reach out to the nature, severity, or frequency of suspected problems in event reports or in the published literature
- 2. The FDA considers that obtaining more real-world clinical data is necessary for public benefit
- 3. Premarket testing data is not enough to provide safety
- 4. The devices happen unexpected or unexplained serious events occur after a device is marketed
In general, the FDA will inform the applicants and invite them to discuss the action plan of 522 postmarket surveillance studies. The longest of the surveillance period is 36 months, unless the FDA judges the necessity to extend. After both sides form an agreement on the action plan, the Center for Devices and Radiological Health (CDRH) would post the action plan and timeline for a track report on the 522 postmarket surveillance studies system. The applicants also can view information on the system to check the status.
- 522 Postmarket Surveillance Studies Program
- Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act
- 522 Postmarket Surveillance Studies Database