{"id":545,"date":"2016-06-17T19:21:05","date_gmt":"2016-06-17T19:21:05","guid":{"rendered":"https:\/\/awrightpath.net\/?p=545"},"modified":"2019-06-05T19:22:39","modified_gmt":"2019-06-05T19:22:39","slug":"fda-releases-evaluation-and-reporting-of-age-race-and-ethnicity-data-in-medical-device-clinical-studies-draft-guidance","status":"publish","type":"post","link":"https:\/\/awrightpath.net\/fda-releases-evaluation-and-reporting-of-age-race-and-ethnicity-data-in-medical-device-clinical-studies-draft-guidance\/","title":{"rendered":"FDA Releases ?Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies? Draft Guidance"},"content":{"rendered":"\n<p>Today we released the ?<a href=\"http:\/\/www.fda.gov\/downloads\/MedicalDevices\/DeviceRegulationandGuidance\/GuidanceDocuments\/UCM507278.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies<\/a>? draft guidance, which provides recommendations to improve the quality, consistency and transparency of data on how&nbsp; medical devices perform within specific age, race, and ethnic groups.&nbsp; Proper evaluation and reporting of this data can benefit patients, clinicians, researchers and regulators.<\/p>\n\n\n\n<p>The specific objectives of this guidance are to:<\/p>\n\n\n\n<ol><li>Encourage the collection and consideration of age, race, ethnicity and associated predictive variables (e.g., body size, biomarkers, bone density, etc.) during the study design stage;<\/li><li>Outline recommended analyses of study subgroup data, with a framework for considering demographic data when interpreting overall study outcomes; and<\/li><li>Specify the FDA?s expectations for reporting age, race, and ethnicity-specific information in summaries and labeling for approved or cleared medical devices.<\/li><\/ol>\n\n\n\n<p>This draft guidance is not for implementation until final.&nbsp; When finalized, this guidance will extend the policy set forth in the FDA?s&nbsp;<a href=\"http:\/\/www.fda.gov\/downloads\/medicaldevices\/deviceregulationandguidance\/guidancedocuments\/ucm283707.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Evaluation of Sex-Specific Data in Medical Device Clinical Studies<\/a>&nbsp;guidance document. &nbsp;The FDA intends to integrate the final contents of both guidance documents into one final guidance document.<\/p>\n\n\n\n<p>We welcome your comments regarding this draft guidance.&nbsp; The comment period will be open for 90 days in the&nbsp;<a href=\"https:\/\/federalregister.gov\/a\/2016-14461\" target=\"_blank\" rel=\"noreferrer noopener\">Federal Register<\/a>under docket number FDA-2016-D-0734 starting June 20, 2016.<\/p>\n\n\n\n<p>If you have any questions, please contact the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health (CDRH) at&nbsp;<a href=\"tel:1-800-638-2041\" target=\"_blank\" rel=\"noreferrer noopener\">1-800-638-2041<\/a>,&nbsp;<a href=\"tel:301-796-7100\" target=\"_blank\" rel=\"noreferrer noopener\">301-796-7100<\/a>&nbsp;or&nbsp;<a href=\"mailto:dice@fda.hhs.gov\" target=\"_blank\" rel=\"noreferrer noopener\">dice@fda.hhs.gov<\/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 we released the ?Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies? draft guidance, which provides recommendations to improve the quality, consistency and transparency of data on how&nbsp; medical devices perform within specific age, race, and ethnic groups.&nbsp; Proper evaluation and reporting of this data can benefit patients, clinicians, [&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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