Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of the final guidance entitled ``Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices; Guidance for Industry and Food and Drug Administration Staff.'' This guidance explains the circumstances in which it may be appropriate to extrapolate existing medical device data to support pediatric device indications in premarket approval applications (PMAs), humanitarian device exemptions (HDEs) and de novo requests. This guidance also describes FDA's approach for determining whether extrapolation may be appropriate and the factors that should be considered within a statistical model for extrapolation. Extrapolation may be appropriate when there are few differences in safety or effectiveness of the proposed device when used in adult as compared to the intended pediatric populations and the adult data are of high quality for borrowing.