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# Q&A Page For Device Adverse Event Reports
- URL: https://www.fdaweb.com/q-a-page-for-device-adverse-event-reports/
- Published: 2020-06-15T12:00:00.000Z
- Updated: 2026-09-14T16:18:11.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5147007

FDA has posted a “question and answer” [Web page](https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/adverse-event-reporting-medical-devices-under-emergency-use-authorization-eua-or-discussed-covid-19?ref=fdaweb.com) to address adverse event reporting for medical devices distributed under Emergency Use Authorizations (EUAs) or that are the subject of [Covid-19-related guidance documents](https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders?ref=fdaweb.com). The page also points out a number of adverse event reporting-related resources.  
  
Under FDA’s regulations, device manufacturers must submit MDRs electronically. Submission of MDRs using the eMDR pathway requires the creation of an account capable of submitting reports to the FDA-wide [Electronic Submissions Gateway](https://www.fda.gov/industry/electronic-submissions-gateway?ref=fdaweb.com) and the completion of [FDA Form 3500A](https://www.fda.gov/safety/medical-product-safety-information/medwatch-forms-fda-safety-reporting?ref=fdaweb.com) in electronic format to capture the event information, the agency says. FDA says that the time frame for submitting an MDR is within either five or 30 days of the manufacturer becoming aware of the event and is not based on the time that the event occurred.