{"id":564,"date":"2016-03-31T19:38:45","date_gmt":"2016-03-31T19:38:45","guid":{"rendered":"https:\/\/awrightpath.net\/?p=564"},"modified":"2019-06-05T19:40:06","modified_gmt":"2019-06-05T19:40:06","slug":"new-emdr-webpages-available-to-help-with-submissions","status":"publish","type":"post","link":"https:\/\/awrightpath.net\/new-emdr-webpages-available-to-help-with-submissions\/","title":{"rendered":"New eMDR Webpages Available to Help with Submissions"},"content":{"rendered":"\n<p>The FDA has added new information on our webpages about adverse event reporting requirements. The&nbsp;<a href=\"http:\/\/www.fda.gov\/MedicalDevices\/DeviceRegulationandGuidance\/PostmarketRequirements\/ReportingAdverseEvents\/eMDR%E2%80%93ElectronicMedicalDeviceReporting\/default.htm\" target=\"_blank\" rel=\"noreferrer noopener\">Electronic Medical Device Reporting (eMDR) System<\/a>&nbsp;webpages help manufacturers, importers and health care facilities understand eMDR requirements and how to submit medical device reports electronically.<\/p>\n\n\n\n<p>On August 14, 2015, the eMDR final rule went into effect, requiring manufacturers and importers to submit medical device reports to the FDA electronically rather than in paper form. Electronic submission expedites report processing and reduces the burden of data entry on the FDA, manufacturers, health care facilities, and importers.<br>The new pages are:<\/p>\n\n\n\n<ul><li><a href=\"http:\/\/www.fda.gov\/MedicalDevices\/DeviceRegulationandGuidance\/PostmarketRequirements\/ReportingAdverseEvents\/eMDR%E2%80%93ElectronicMedicalDeviceReporting\/ucm475298.htm\" target=\"_blank\" rel=\"noreferrer noopener\">How to Enroll in eMDR Program<\/a>&nbsp;provides detailed instructions for enrolling in the eMDR program and completing the required guidance-compliant test submissions.<\/li><li><a href=\"http:\/\/www.fda.gov\/MedicalDevices\/DeviceRegulationandGuidance\/PostmarketRequirements\/ReportingAdverseEvents\/eMDR%E2%80%93ElectronicMedicalDeviceReporting\/ucm475302.htm\" target=\"_blank\" rel=\"noreferrer noopener\">eMDR Help and FAQs<\/a>&nbsp;provides answers to common questions and who to contact when specific concerns arise.<\/li><li><a href=\"http:\/\/www.fda.gov\/MedicalDevices\/DeviceRegulationandGuidance\/PostmarketRequirements\/ReportingAdverseEvents\/eMDR%E2%80%93ElectronicMedicalDeviceReporting\/ucm475303.htm\" target=\"_blank\" rel=\"noreferrer noopener\">eMDR System Enhancements<\/a>&nbsp;describes updates made to improve the eMDR system.<\/li><\/ul>\n\n\n\n<p>For eMDR submission questions, contact the appropriate help desk listed at the eMDR Help and FAQs page.<\/p>\n\n\n\n<p>Thank you,<br>Food and Drug Administration<br>Center for Devices and Radiological Health<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The FDA has added new information on our webpages about adverse event reporting requirements. The&nbsp;Electronic Medical Device Reporting (eMDR) System&nbsp;webpages help manufacturers, importers and health care facilities understand eMDR requirements and how to submit medical device reports electronically. On August 14, 2015, the eMDR final rule went into effect, requiring manufacturers and importers to submit [&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>New eMDR Webpages Available to Help with Submissions - A Wright Path | Right Path. Right Now!<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/awrightpath.net\/new-emdr-webpages-available-to-help-with-submissions\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"New eMDR Webpages Available to Help with Submissions - A Wright Path | Right Path. Right Now!\" \/>\n<meta property=\"og:description\" content=\"The FDA has added new information on our webpages about adverse event reporting requirements. The&nbsp;Electronic Medical Device Reporting (eMDR) System&nbsp;webpages help manufacturers, importers and health care facilities understand eMDR requirements and how to submit medical device reports electronically. 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