{"id":543,"date":"2016-06-21T19:18:34","date_gmt":"2016-06-21T19:18:34","guid":{"rendered":"https:\/\/awrightpath.net\/?p=543"},"modified":"2019-06-05T19:20:39","modified_gmt":"2019-06-05T19:20:39","slug":"cdrh-industry-announcing-fda-final-guidance-and-webinar-on-leveraging-existing-clinical-data-for-extrapolation-to-pediatric-uses-of-medical-devices","status":"publish","type":"post","link":"https:\/\/awrightpath.net\/cdrh-industry-announcing-fda-final-guidance-and-webinar-on-leveraging-existing-clinical-data-for-extrapolation-to-pediatric-uses-of-medical-devices\/","title":{"rendered":"CDRH Industry: Announcing FDA Final Guidance and Webinar on ?Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices?"},"content":{"rendered":"\n<p>Today the FDA published a&nbsp;<a href=\"http:\/\/www.fda.gov\/downloads\/MedicalDevices\/DeviceRegulationandGuidance\/GuidanceDocuments\/UCM444591.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">final guidance<\/a>, 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&nbsp;<em>de novo<\/em>requests. This guidance facilitates continued efforts to address unmet medical device needs for pediatric patients.<\/p>\n\n\n\n<p>This guidance:<\/p>\n\n\n\n<ul><li>explains the conditions in which FDA believes it may be appropriate to leverage existing clinical data to support pediatric device indications and labeling;<\/li><li>outlines the approach FDA uses to determine whether extrapolation is appropriate and to what extent; and<\/li><li>describes statistical methodology that can be used to leverage data for pediatric implications.<\/li><\/ul>\n\n\n\n<p>FDA will discuss this final guidance document&nbsp;at a webinar scheduled for&nbsp;August 8, 2016.&nbsp; The webinar is intended to help manufacturers and other interested stakeholders understand the information provided in this final guidance document.<\/p>\n\n\n\n<p>Following a brief presentation, the FDA will respond to questions regarding this guidance document.<\/p>\n\n\n\n<p><strong>Webinar details:<\/strong><br><em>Registration is not necessary.<\/em><\/p>\n\n\n\n<ul><li>Date: August 8, 2016<\/li><li>Time:&nbsp;1:00 PM ? 2:30 PM ET<\/li><li>To hear the presentation and ask questions: Dial:&nbsp;<a href=\"tel:888-603-7015\" target=\"_blank\" rel=\"noreferrer noopener\">888-603-7015<\/a>; passcode:&nbsp;3007138&nbsp;| International:&nbsp;<a href=\"tel:1-517-308-9255\" target=\"_blank\" rel=\"noreferrer noopener\">1-517-308-9255<\/a>; passcode:3007138<\/li><li>To view the slide presentation during the webinar:&nbsp;<a href=\"https:\/\/www.mymeetings.com\/nc\/join.php\" target=\"_blank\" rel=\"noreferrer noopener\">https:\/\/www.mymeetings.com\/nc\/join.php?i=PW8996213&amp;p=3007138&amp;t=c<\/a><\/li><\/ul>\n\n\n\n<p>Following the webinar, a transcript, recording and slides will be available at:&nbsp;<a href=\"http:\/\/www.fda.gov\/CDRHWebinar\" target=\"_blank\" rel=\"noreferrer noopener\">http:\/\/www.fda.gov\/CDRHWebinar<\/a>. The slide presentation will be available at this site on the morning of the webinar.<\/p>\n\n\n\n<p>If you have any general questions about this guidance document, please contact CDRH?s Division of Industry and Consumer Education (DICE) at&nbsp;<a href=\"mailto:dice@fda.hhs.gov\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>dice@fda.hhs.gov<\/strong><\/a>,&nbsp;<a href=\"tel:1-800-638-2041\" target=\"_blank\" rel=\"noreferrer noopener\">1-800-638-2041<\/a>, or&nbsp;<a href=\"tel:301-796-7100\" target=\"_blank\" rel=\"noreferrer noopener\">301-796-7100<\/a>.<\/p>\n\n\n\n<p>Food and Drug Administration<br>Center for Devices and Radiological Health<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Today the FDA published a&nbsp;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&nbsp;de novorequests. This guidance facilitates continued efforts to address unmet medical device needs for pediatric patients. This guidance: explains the conditions in which [&hellip;]<\/p>\n","protected":false},"author":10,"featured_media":335,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[8,9],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v20.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>A Wright Path | Right Path. 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