viernes, 5 de agosto de 2016

CDRH Industry: REMINDER: Webinar on “Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices” Final Guidance

On June 21st, 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 novo requests. This guidance facilitates continued efforts to address unmet medical device needs for pediatric patients. 
FDA will discuss this final guidance document at a webinar scheduled on Monday 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.
Following the webinar, a transcript, recording and slides will be available at: 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, 1-800-638-2041, or 301-796-7100.

Food and Drug Administration
Center for Devices and Radiological Health

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