As a result of the Coronavirus Disease 2019 (COVID-19) pandemic and under the authority of section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act, the FDA has issued numerous Emergency Use Authorizations (EUAs) for medical devices intended to diagnose, prevent, or treat COVID-19. In addition, the FDA has issued several COVID-19-related guidance documents intended to help increase the availability and capability of certain types of medical devices used during the COVID-19 pandemic.
This page answers questions about adverse event reporting for medical devices distributed under Emergency Use Authorizations (EUAs) or that are the subject of COVID-19-related guidance documents and points out a number of adverse event reporting-related resources.
Q: What are the adverse event reporting requirements for manufacturers of medical devices under an EUA?
A: Each Emergency Use Authorization (EUA) includes Conditions of Authorization that specify the adverse event reporting requirements for authorized devices. Generally, each EUA includes a condition that the EUA holder follow the reporting requirements in 21 CFR Part 803. Manufacturers should refer to their EUA letter for a given authorized device for the particular reporting requirements. MDRs for EUA devices can be submitted via the same mechanisms used for non-EUA devices.
Medical device reporting under 21 CFR Part 803 generally requires reporting of deaths, serious injuries, and malfunctions that have, may have, or would be likely to cause or contribute to a death or serious injury. For more information regarding adverse event reporting for authorized medical devices, please refer to Section III.E.2 of the FDA guidance document, Emergency Use Authorization of Medical Products and Related Authorities. General information about reporting MDRs under 21 CFR Part 803 can be found on FDA’s webpage: Mandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities.
Q: How do manufacturers submit an MDR for their medical devices?
A: FDA has established an Electronic Medical Device Reporting (eMDR) system, as described in FDA’s guidance document, Questions and Answers about eMDR - Electronic Medical Device Reporting. Submission of MDRs using the eMDR system involves creating an account capable of submitting reports to the FDA-wide Electronic Submissions Gateway and the completion of FDA Form 3500A in electronic format to capture the event information.
As part of creating an eMDR gateway account for submitting MDRs, a device establishment typically provides the FDA Establishment Identifier (FEI) number received as part of the Registration and Listing process. In some instances, FEI numbers are created outside of the Registration and Listing process. To retrieve an FEI number assigned to your device establishment, you may visit the FEI Search Portal. If an FEI has not been previously assigned, you can request an FEI number by email (see below).
Also see the question below, Q: What product codes should be used when preparing adverse event reports for these products?, for more information on what to include in the MDR.
Q: How does a device establishment create an eMDR account if it is not required to register and list?
A: If your device establishment is not required to register and list, but you are seeking to submit MDRs for a device available under EUA or following an Enforcement Policy Guidance for a COVID-19-related medical device, you can request an FEI number by email to [email protected] by including the following information:
- Device establishment name and address
- Device Owner Operator number (if known)
- Establishment type
- Device panel
- Official correspondent name, email, and telephone number
- U.S. Agent name, email, and telephone number (for foreign device establishments)
There is no cost associated with requesting an FEI number. Before requesting an FEI number, device establishments should check the FEI Search Portal to ensure a number has not already been assigned to them.
Creating an FEI number in this way is not a substitute for Registration and Listing and does not satisfy any Registration and Listing requirements. Device establishments wishing to register and list should follow the Registration and Listing process listed on the FDA website.
For more information regarding the electronic submission of MDRs, please refer to the FDA guidance document, Questions and Answers about eMDR - Electronic Medical Device Reporting. In addition, see eMDR – Electronic Medical Device Reporting for details on how to set up an account for submitting these reports.
Q: What are the specified time frames for submitting MDRs?
A: According to the Code of Federal Regulations, 21 CFR Part 803, manufacturers must submit MDRs to the FDA no later than 30 calendar days after becoming aware of the reportable event, or within 5 calendar days for events necessitating remedial action to prevent a risk of substantial harm to the public health.
Q: What if COVID-19 related issues impact the time it takes for a device establishment to become aware of a reportable event for a medical device under EUA?
A: As mentioned above, the time frame for submitting an MDR is within either 5 or 30 days of the manufacturer becoming aware of the event and is not based on the time that the event occurred. The manufacturer is required to submit MDRs within the time frame after becoming aware of an adverse event.
Q: The FDA recently re-issued a guidance document, Guidance for Industry: Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic. Do the adverse event reporting recommendations in this guidance document apply to medical devices under EUA?
A: The guidance does not apply to medical devices under EUA. Page 2 of the guidance states that, “… this guidance does not address monitoring and reporting of adverse events that might be imposed as a condition for medical products authorized for emergency use under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360bbb-3).” The EUAs issued for medical devices in response to COVID-19 all include adverse event reporting Conditions of Authorization.
Q: What are the reporting expectations for patients, health care professionals, and consumers using medical devices under EUA?
A: Patients, health care professionals, and consumers who experience a problem with a medical device under an EUA are encouraged to report these problems to the FDA. These reports can provide important safety information that complements information submitted by manufacturers. Such reports can be submitted to the FDA through MedWatch, the FDA Safety Information and Adverse Event Reporting Program, using the following methods:
- Complete the MedWatch Online Reporting Form
- Download form or call 1-800-332-1088 to request a reporting form, and complete and return to the address on the pre-addressed form.
Q: If a medical device is discussed in a COVID-19-related guidance document, does this impact the reporting requirements for the device?
A: None of the enforcement policies provided in the COVID-19-related guidance documents affect the reporting requirements under 21 CFR Part 803 for medical devices offered as outlined in those guidances. As a result, manufacturers, importers, and device user facilities are expected to follow the reporting requirements under 21 CFR Part 803. For more information about reporting during the COVID-19 pandemic, see the FDA guidance document, Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic.
Q: What product codes are to be used when preparing adverse event reports for devices authorized under an EUA?
A: When submitting MDRs, the product code is used to ensure the MDR can be appropriately analyzed and reduce the need for follow-up from the FDA. Medical devices for COVID-19 that have been granted Emergency Use Authorization (EUA) and their respective product codes are listed on the Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices web page.
The list below includes product codes for some of the medical devices that are currently authorized under EUAs:
- In Vitro Diagnostics EUAs
- Blood Purification Devices EUAs
- Continuous Renal Replacement Therapy and Hemodialysis Devices EUAs
- Infusion Pump EUAs
- Personal Protective Equipment EUAs
- Remote or Wearable Patient Monitoring Devices EUAs
- Respiratory Assist Devices EUAs
- Ventilators and Ventilator Accessories EUAs
Q: Whom should I contact if I have any questions about adverse event reporting for my medical device?
A: If you have a general question related to adverse event reporting for medical devices under EUA or that are the subject of COVID-19-related guidance documents, send an email to [email protected].