calcification of tissue-based heart valves and the migration of craniofixation devices are additional cases in point.
FDA’s regulatory and other activities take each of the modes of problem identification into account. Thus, FDA provides guidance on device design and testing and evaluates information on safety prior to approval or clearance of devices. Through the agency’s adverse event reporting program and requirements for postmarket studies of certain devices, it focuses on safety after devices are marketed. As described in this report, these postmarket strategies have serious limitations. Identification and prevention of problems with devices prior to marketing are, in any case, preferable to postmarket detection.
This chapter has provided a pediatric context for a report that often must focus on policies, practices, and questions that are not specific to children. The next reviews the regulatory framework for FDA’s activities. With a few exceptions, that framework applies to both adults and children.