{"id":1910,"date":"2019-09-27T11:25:00","date_gmt":"2019-09-27T11:25:00","guid":{"rendered":"http:\/\/localhost\/vistaar.ai\/?p=1910"},"modified":"2024-06-05T09:35:10","modified_gmt":"2024-06-05T09:35:10","slug":"usa-fda-drafts-guidance-on-patient-engagement-in-device-trials","status":"publish","type":"post","link":"https:\/\/stage-websites.ddismart.com\/vistaar\/blog\/usa-fda-drafts-guidance-on-patient-engagement-in-device-trials\/","title":{"rendered":"USA: FDA Drafts Guidance on Patient Engagement in Device Trials"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">The US Food and Drug Administration (FDA) has published draft guidance on how device manufacturers <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">should engage patients when designing medical devices.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>This Draft Guidance is Intended to:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Help sponsors understand how they can use patient engagement to elicit experience, perspectives, and other relevant information from patient advisors to improve the design and conduct of clinical investigations;<\/li>\n\n\n\n<li>Highlight the benefits of engaging with patient advisors early in the medical device development process;<\/li>\n\n\n\n<li>Illustrate which patient engagement activities are generally not considered by the FDA to constitute research or activity subject to FDA\u2019s regulations, including regulations regarding institutional review boards (IRBs); and<\/li>\n\n\n\n<li>Address common questions and misconceptions about collecting and submitting to FDA patient engagement information.<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Patient engagement in device designing takes their experiences into account and addresses the various perspectives, misconceptions, and questions.<\/p>\n","protected":false},"author":1,"featured_media":1877,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[645],"tags":[],"class_list":["post-1910","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-device"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.5 - 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