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On Monday, August 8, 2016, the FDA hosted a webinar to share information and answer questions about its final guidance: Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices. This final guidance, issued on June 21, provides a framework to consider extrapolating existing data to evaluate a device’s performance in pediatric patients in pre-market approval applications (PMAs), humanitarian device exemptions (HDEs) and de novo requests. It also facilitates continued efforts to address unmet medical device needs for pediatric patients.

This guidance:

• explains the conditions in which FDA believes it may be appropriate to leverage existing clinical data to support pediatric device indications and labeling;
• outlines the approach FDA uses to determine whether extrapolation is appropriate and to what extent; and
• describes statistical methodology that can be used to leverage data for pediatric implications.

FDA discussed this final guidance document at a webinar scheduled for August 8, 2016. The webinar is intended to help manufacturers and other interested stakeholders understand the information provided in this final guidance document.

Following a brief presentation, the FDA responded to questions regarding this guidance document.

Target audience: Industry

If you have any general questions about this guidance document, please contact CDRH’s Division of Industry and Consumer Education (DICE) at [email protected], 1-800-638-2041, or 301-796-7100.

Food and Drug Administration
Center for Devices and Radiological Health