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Safe Medical Devices for Children
ies in their annual reports. The committee considers the AdvaMed report encouraging for the studies it covered. It does not affect the committee’s judgment that the agency must have an effective system for monitoring and reporting of the status of postmarket device studies.
In an effort to learn more about study commitments, committee staff read individual, online approval letters for the period from January 1, 2001, through December 31, 2004. Of the 168 letters read, 74 had some provision for postmarket study or information collection. As discussed in Chapter 6, some provisions involved pediatric use of a device. The committee could not review most approvals of PMA supplements (which may include study provisions or approve study protocols) because few are available online. The committee also identified postmarket study commitments in the online letters of approval for humanitarian device exemptions. Among six such devices explicitly approved for use with children since December 1997, one—for a left ventricular assist device—was subject to requirements for further study (H030003, FDA, 2004a).
The committee did not attempt to determine the specific status of the study commitments it identified. (It expects that many, if not most, studies would not yet be completed and that the most recently ordered studies might not have started.) As described in Chapter 3, study protocols and findings are considered confidential unless the findings lead to a public health notification or similar action.
Taken together, the information available to the committee paints a disappointing picture of the agency’s performance in monitoring study commitments for medical devices, particularly given the criticism directed at the agency in the 1996 OIG report on the monitoring of postmarket drug studies. Agency staff report that they are working to create a system to track what postmarket study commitments exist and where they stand in terms of progress toward completion (Tillman and Gardner, 2004). Committee recommendations appear at the end of this chapter.
In response to the committee’s question about postmarket studies involving devices used with children or devices with possible pediatric as well as adult uses, the agency stated that it had not recorded such information in the past. Because the Medical Device User Fee and Modernization Act of 2002 provided that user fees for PMA applications and 510(k) notifications be waived for devices intended solely for pediatric use, the agency will be able in the future to identify those applications and any studies associated with those devices. Such applications, by definition, do not involve devices with possible pediatric applications that are approved or cleared based on studies with adults. Thus, this mechanism will not help identify studies related to pediatric use of these devices.