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/join.php?i=PW8996213&p=3007138&t=c
Following the webinar, a transcript, recording and slides will be available at: http://www.fda.gov/CDRHWebinar. The slide presentation will be available at this site on the morning of the webinar.
If you have any general questions about this guidance document, please contact CDRH’s Division of Industry and Consumer Education (DICE) at email@example.com, 1-800-638-2041, or 301-796-7100.
Food and Drug Administration
Center for Devices and Radiological Health