lunes, 18 de mayo de 2015

Reminder: Announcing FDA Webinar and Draft Guidance, “Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices”

On April 30, 2015, FDA published a draft guidance, which provides a framework under which to consider extrapolating existing adult clinical medical device data to evaluate a device’s performance in pediatric patients in pre-market approval applications (PMAs) and humanitarian device exemptions (HDEs). This draft guidance facilitates continued efforts to address the unmet medical device need for pediatric patients.
We will discuss this draft guidance document at a webinar scheduled on Tuesday May 19, 2015. The webinar is intended to help manufacturers and other interested stakeholders understand the information provided in this draft guidance document.
Webinar details:
Registration is not necessary.
Date: Tuesday May 19, 2015
Time: 2:30 PM-4:00 PM, Eastern Time (please connect by 2:15 PM)
To hear the presentation and ask questions:
Dial: 888-469-0695; passcode: 7702741 | International: 1-312-470-7233; passcode: 7702741
To view the slide presentation during the webinar:
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.

Food and Drug Administration
Center for Devices and Radiological Health

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