Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices
May 4, 2015 (All day)
The FDA has published a draft guidance document entitled “Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices.” The objectives are: (1) to increase the availability of safe and effective pediatric devices by leveraging relevant existing clinical data for use in pre-market approval applications (PMAs) and humanitarian device exemptions (HDEs); (2) to explain the circumstances in which FDA believes it may be appropriate to leverage existing clinical data to support pediatric device indications and labeling; (3) to outline the approach FDA uses to determine whether extrapolation is appropriate, and if so, to what extent the data can be leveraged; and (4) to describe statistical methodology that can be used to leverage the data in a way that increases precision for pediatric inferences.
