Today the FDA published a final guidance, which 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 novorequests. This guidance facilitates continued efforts to address unmet medical device needs for pediatric patients.
- 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 will discuss 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 will respond to questions regarding this guidance document.
Registration is not necessary.
- Date: August 8, 2016
- Time: 1:00 PM – 2:30 PM ET
- To hear the presentation and ask questions: Dial: 888-603-7015; passcode: 3007138 | International: 1-517-308-9255; passcode:3007138
- To view the slide presentation during the webinar: https://www.mymeetings.com/nc/
Following the webinar, a transcript, recording and slides will be available at: http://www.fda.gov/CDRHWebinar
Food and Drug Administration
Center for Devices and Radiological Health