Monday, August 1, 2016
FDA Publishes Several Final Guidance Documents
Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices
In the June 21, 2016 Federal Register, the FDA announced the availability of the guidance titled “Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices.” This guidance explains the circumstances in which it may be appropriate to extrapolate existing medical device data to support pediatric device indications in several marketing applications. This guidance also describes the 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.