keting of a device is permitted, this report refers to both types of studies collectively as postmarket study commitments.
The statutory provisions for postmarket studies reflect Congressional awareness that the data and assessments associated with the approval or clearance of a complex medical device may leave meaningful unanswered questions about uncommon adverse events, effects in groups not studied (e.g., children), and long-term effects. To the extent that FDA encourages and accepts smaller, faster, and otherwise more limited studies to promote earlier consideration of a device for approval and reduce burdens on sponsors, more questions may remain for the postmarket period. Thus, attention to the specification and monitoring of postmarket study commitments becomes more critical.
This chapter examines FDA’s monitoring of the status and fulfillment of commitments for postmarket studies of medical devices. It starts by providing some background on concerns about the monitoring of postmarket studies as they initially arose with pharmaceutical products. It also describes growing interest in public access to information about findings from such studies through some kind of clinical trials registry. The chapter then reviews the FDA’s monitoring of postmarket study commitments for devices. The final section presents the committee’s conclusions and recommendations about monitoring and public information. The discussion of trade secrets and confidentiality in Chapter 3 provides important additional context.
This chapter does not report on studies that sponsors initiate voluntarily. Sponsors often undertake such studies to support expansions in the labeling of a device to cover new uses or populations. Voluntary studies may also be negotiated between sponsors and FDA at the time a device is approved, possibly as an alternative to a required study. In addition, sponsors may initiate further studies to provide information sought by Medicare and private health plans to guide coverage decisions. Recent years have seen Medicare and some other health insurers become interested in supporting clinical trials of some innovative products or procedures as a way of obtaining better data for clinical and coverage decision making (see, e.g., IOM, 2000a).1
In 2000, the President issued an executive memorandum that, in essence, directed the Medicare program to pay the routine costs of patient care and the costs of treating medical complications associated with participation in clinical trials (CMS, no date). The Centers for Medicare and Medicaid Services (CMS) recently announced related initiatives, including that Medicare would cover positron emission tomography (PET) for some Medicare beneficiaries who are at risk for Alzheimer’s disease and who enroll in a clinical trial approved by Medicare (CMS, 2004).