FDA announces webinar, open comment period for device draft guidance

The FDA published draft guidance on April 30 that provides a framework under which to consider extrapolating existing adult clinical medical device data to evaluate a device’s performance in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This draft guidance facilitates continued efforts to address the unmet medical device need for pediatric patients. The agency seeks public comment, which opened on May 6 for the next 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This draft guidance explains the conditions in which FDA believes it may be appropriate to leverage existing clinical data to support pediatric device indications and labeling;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.

FDA will host a webinar to provide clarification, answer questions and encourage feedback during the open comment period on May 19.. The webinar is intended to help manufacturers and other interested stakeholders understand the information provided in this draft guidance document.

Find call-in information and access to the slide presentation on the FDA website.