News: Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or Discussed in COVID-19-Related Guidance Documents
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 which specify the adverse event reporting requirements for each authorized device. Generally, each EUA includes the requirement that the device manufacturer follow the reporting requirements stated in 21 CFR Part 803, including the submission of Medical Device Reports (MDRs) for reportable adverse events. Please refer to the corresponding EUA letter for the particular reporting requirements for a given authorized device.
For more information regarding adverse event reporting conditions 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. In addition, see Mandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities for general information on the reporting requirements for medical device manufacturers under 21 CFR Part 803.
Q: How do manufacturers submit an MDR for their medical devices?
A: Under FDA regulations, manufacturers must submit MDRs electronically. As described in FDA’s guidance document, Questions and Answers about eMDR - Electronic Medical Device Reporting, manufacturers submit these reports using the FDA’s Electronic Medical Device Reporting (eMDR) system. Submission of MDRs using the eMDR pathway involves creation of 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.
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 manufacturers to submit 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 manufacturer 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 users of 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, the reporting requirements under 21 CFR Part 803 must be followed for these medical devices. See more information in the FDA guidance document, Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic.
Q: What product codes should be used when preparing adverse event reports for these products?
A: When submitting MDRs, it is important to include the appropriate product code for the medical device in question to ensure the MDR can be appropriately analyzed and minimize the need for follow-up from the FDA. The FDA’s product classification database can be used to search for the relevant product code for the medical device on which you are reporting.
This table lists product codes for some of the medical devices currently covered by existing EUAs or discussed in COVID-19-related guidances:
|Device Type||Product Code|
|Face masks (except N95 respirators) for general public/health care use||QKR|
|In vitro diagnostic devices: 2019-Novel coronavirus nucleic acid reagent||QJR|
|In vitro diagnostic devices: Coronavirus serological reagents||QKO|
|In vitro diagnostic devices: Coronavirus antigen detection test systems||QKP|
|In vitro diagnostic devices: Microbial nucleic acid storage and stabilization media||QBD|
|Protective barrier enclosure||QLD|
|Protective barrier enclosure: With negative pressure||QLE|
|Respirator decontamination systems||QKY|
|Respirators: NIOSH-certified N95 respirator for use by the general public in public health medical emergencies||NZJ|
|Respirators: Non-NIOSH-approved disposable filtering facepiece respirators (FFRs):||QKU|
For ventilators, please refer to the FDA guidance, Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency, for assistance with identifying product codes for ventilators and associated accessories.
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 affected by COVID-19-related guidance documents, send an email to COVID19-DeviceReporting@fda.hhs.gov.