{"id":18176,"date":"2021-05-18T16:21:16","date_gmt":"2021-05-18T14:21:16","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=18176"},"modified":"2023-01-25T17:29:01","modified_gmt":"2023-01-25T16:29:01","slug":"adverse-events-what-should-md-ivd-manufacturers-do-according-to-fda","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2021\/05\/18\/adverse-events-what-should-md-ivd-manufacturers-do-according-to-fda\/","title":{"rendered":"Adverse Events: what should MD and IVD Manufacturers do according to FDA?"},"content":{"rendered":"\r\n

In the United States, according to the Medical Device Reporting: Electronic Submission Requirements (eMDR)<\/strong>, the Food and Drug Administration (FDA) requires Manufacturers<\/strong> of Medical Devices (MD) and In Vitro Diagnostic Medical Devices (IVD) selling in the U.S.,<\/strong> to report any occurred or potential adverse<\/strong> events related to their Medical Devices<\/strong>.<\/p>\r\n\r\n\r\n\r\n

\"Adverse\r\n
Adverse Events: what should MD and IVD Manufacturers do according to FDA?<\/figcaption>\r\n<\/figure>\r\n\r\n\r\n\r\n

The reporting must be sent to the FDA in two cases, that is, if evidence suggests that the device has caused or has contributed to a patient\u2019s death or serious injury<\/strong>, or if the device has malfunctioned and would be likely to cause or contribute to a death or serious injury if these malfunctions were to recur.<\/p>\r\n\r\n\r\n\r\n

We point out that FDA considers an adverse event<\/strong> any undesirable experience<\/strong> or side effect<\/strong> associated with the use of a medical device or product that results in unintentional and undesirable harm to the patient.<\/p>\r\n\r\n\r\n\r\n

Why and how to report adverse events to FDA<\/strong><\/h2>\r\n\r\n\r\n\r\n

As set forth by the regulation, Manufacturers of Medical Devices and In Vitro Diagnostic Medical Devices shall inform the FDA when one of their devices may have caused or contributed to a patient\u2019s death or serious injury.<\/p>\r\n\r\n\r\n\r\n

In all of these cases Manufacturers must submit adverse events reports in an electronic format (Electronic Medical Device eMDR Reporting)<\/strong> by installing specific software<\/strong> and applying a very complex and sometimes problematic approval procedure<\/strong>.<\/p>\r\n\r\n\r\n\r\n

One of the most valid tools is the eSubmitter software<\/strong>, which allows the creation of various electronic documents, such as the file for reporting adverse events related to Medical Devices.<\/p>\r\n\r\n\r\n\r\n

Instead, Manufacturers shall send their reports through MedWatch<\/strong>, that is the FDA Safety Information and Adverse Event-Reporting Program.<\/p>\r\n\r\n\r\n\r\n

Thanks to the Medical Device Reporting: Electronic Submission Requirements<\/strong> (eMDR) <\/strong>it is possible to monitor device problems in post-market surveillance and to take action in good time.<\/p>\r\n\r\n\r\n\r\n

In complying with FDA requirements, another important aspect to consider is the timing of reporting of adverse events<\/strong>, which varies depending on the severity of the incident. If the device has caused or contributed to a patient\u2019s serious injury or death, it is necessary to make an electronic Medical Device Report (eMDR) to the FDA within 30 days<\/strong>. On the other hand, where corrective action is required to prevent a reasonable risk of substantial harm to public health, FDA requires adverse eventsto \u00a0be reported within only 5 days<\/strong>.<\/p>\r\n\r\n\r\n\r\n

Do you want specialists to do the Adverse Event Reporting for you?<\/strong><\/h2>\r\n\r\n\r\n\r\n

Choose Thema as your US Electronic Medical Device Reporting delegate!<\/strong><\/h3>\r\n\r\n\r\n\r\n

Thema is equipped with all the necessary<\/strong> tools<\/strong> and resources<\/strong> to provide the service of US Electronic Medical Device Reporting,<\/strong> in order to carry out on your behalf all the activities required by the FDA.<\/p>\r\n\r\n\r\n\r\n

If you appoint Thema as your US Electronic Medical Device Reporting delegate, <\/strong>you will receive full support in the activities required by the FDA and enjoy these benefits<\/strong>:<\/p>\r\n\r\n\r\n\r\n