miércoles, 6 de mayo de 2015

Announcing FDA Webinar and Draft Guidance, “Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices”

On April 30, 2015, FDA published a draft guidance, which provides a framework under which to consider extrapolating existing adult clinical medical device data to evaluate a device’s performance in pediatric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 This draft guidance facilitates continued efforts to address the unmet medical device need for pediatric patients.  We welcome your comments and suggestions regarding this draft guidance.  The comment period opened today, May 6, 2015, when the notice of availability published in the Federal Register.  The comment period will be open for 90 days. 
This draft guidance: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 will use to determine whether extrapolation is appropriate and to what extent; and
• describes statistical methodology that can be used to leverage data for pediatric inferences.
On May 19, 2015, FDA will host a webinar to provide clarification, answer questions and encourage feedback during the open comment period. 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webinar is intended to help manufacturers and other interested stakeholders understand the information provided in this draft guidance document.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: http://www.fda.gov/CDRHWebinar. The slide presentation will be available at this site on the morning of the webinar.
We welcome your comments and suggestions regarding this draft guidance. The comment period will be open for 90 days.
If you have any questions regarding this guidance document, please contact CDRH’s Division of Industry and Consumer Education (DICE) at dice@fda.hhs.gov, 1-800-638-2041, or 301-796-7100.

Food and Drug Administration
Center for Devices and Radiological Health

No hay comentarios: