On Monday, August 8, 2016, the FDA will host 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 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.
Webinar Details:
Registration is not necessary.
Date: August 8, 2016
Time: 1:00 PM – 2:30 PM Eastern Time
To ensure you are connected, please dial-in 15 minutes prior to the start of the webinar.
NOTE: You must dial-in 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=PW8996213p=3007138t=c
Following the webinar, a transcript, recording and slides will be available at: http://www.fda.gov/CDRHWebinar. The slide presentation will also be available at this site on the morning of the webinar.
NOTE: The FDA does not provide Continuing Education Credits (CEU) or Certificates of Attendance for webinars.
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
Add this to my Calendar
Outlook users: Click link, select Open, then click Save Close