{"id":2005,"global_id":"research.ncsu.edu\/research-education?id=2005","global_id_lineage":["research.ncsu.edu\/research-education?id=2005"],"author":"280","status":"publish","date":"2023-01-12 11:16:08","date_utc":"2023-01-12 16:16:08","modified":"2023-02-17 10:32:39","modified_utc":"2023-02-17 15:32:39","url":"https:\/\/research.ncsu.edu\/research-education\/event\/irb-topical-workshop-device-research-and-the-fda\/","rest_url":"https:\/\/research.ncsu.edu\/research-education\/wp-json\/tribe\/events\/v1\/events\/2005","title":"IRB Topical Workshop: Device Research and the FDA","description":"<p><a href=\"https:\/\/reporter.ncsu.edu\/link\/instanceview?courseID=LIB-RESRCH-IRBFDA&amp;deptName=LIB&amp;instanceID=000004\">Register for this workshop<\/a><br \/><span><br \/><\/span><br \/><span>This online session will detail information about devices and FDA regulations and when they apply.<\/span><\/p>\n<p>Topics in this session include:<\/p>\n<ul>\n<li>Discussions regarding studying the safety and efficacy of a device<\/li>\n<li>Discussion of significant\/nonsignificant risk devices<\/li>\n<li>Discussion of IDE, Abbreviated IDE, and IDE Exemption<\/li>\n<li>Use on label or off label<\/li>\n<li>Detail PI obligations should the FDA regulations apply<\/li>\n<li>IRB processes regarding medical devices and the FDA<\/li>\n<\/ul>\n<p>There are no required prerequisites but completion of IRB Basics Part I is recommended.<\/p>\n<p>Instructor: Jennie Ofstein<\/p>","excerpt":"","slug":"irb-topical-workshop-device-research-and-the-fda","image":false,"all_day":false,"start_date":"2023-02-17 11:30:00","start_date_details":{"year":"2023","month":"02","day":"17","hour":"11","minutes":"30","seconds":"00"},"end_date":"2023-02-17 13:00:00","end_date_details":{"year":"2023","month":"02","day":"17","hour":"13","minutes":"00","seconds":"00"},"utc_start_date":"2023-02-17 16:30:00","utc_start_date_details":{"year":"2023","month":"02","day":"17","hour":"16","minutes":"30","seconds":"00"},"utc_end_date":"2023-02-17 18:00:00","utc_end_date_details":{"year":"2023","month":"02","day":"17","hour":"18","minutes":"00","seconds":"00"},"timezone":"America\/New_York","timezone_abbr":"EST","cost":"","cost_details":{"currency_symbol":"","currency_code":"","currency_position":"","values":[]},"website":"","show_map":false,"show_map_link":false,"hide_from_listings":false,"sticky":false,"featured":false,"categories":[],"tags":[],"venue":[],"organizer":[],"custom_fields":[],"json_ld":{"@context":"http:\/\/schema.org","@type":"Event","name":"IRB Topical Workshop: Device Research and the FDA","description":"&lt;p&gt;Register for this workshopThis online session will detail information about devices and FDA regulations and when they apply.Topics in this session include:Discussions regarding studying the safety and efficacy of a&hellip;&lt;\/p&gt;\\n","url":"https:\/\/research.ncsu.edu\/research-education\/event\/irb-topical-workshop-device-research-and-the-fda\/","eventAttendanceMode":"https:\/\/schema.org\/OfflineEventAttendanceMode","eventStatus":"https:\/\/schema.org\/EventScheduled","startDate":"2023-02-17T11:30:00-05:00","endDate":"2023-02-17T13:00:00-05:00","performer":"Organization"},"is_virtual":false,"virtual_url":null,"virtual_video_source":""}