How does FDA Learn of postmarket problems or issues with a medical device?
An issue with a device may be identified at any point during the life cycle of the device, by anyone in CDRH (e.g., a reviewer in the Office of Device Evaluation (ODE), a scientist in Office of Science and Engineering Laboratories) and forwarded with the concurrence of his/her Division Director to the Director of Issues Management Staff (IMS) in the Office of Surveillance and Biometrics (OSB). Other sources, e.g., a professional association, an individual clinician, or another Center, may also identify issues. The Director of IMS will assign an Issues Manager to work with the staff identifying the issue to develop the rationale statement for presentation to an expert review team convened for this purpose. This rationale statement will briefly summarize the hazard signal/concern, the applicable safety and effectiveness information (i.e. risks and benefits) , the problem or issue, alternate strategies to resolve the concern, and the question to be addressed if PS is ordered. HOW DOES FDA
