Jun 17, 2020

The US Food and Drug Administration has laid out adverse event reporting expectations for medical devices qualified for distribution under the agency’s Emergency Use Authorization (EUA) program to help combat the COVID-19 public health crisis.

A new Q&A resource published by FDA covers specific adverse vent reporting requirements for devices with EUA designations, as well as report submission rules, timeframes and related rules and recommendations. FDA’s guidelines for adverse event reporting come as many EUA-designated devices including respirators, IVD test kits and personal protective equipment (PPE) have been on the US market for several weeks as the coronavirus pandemic continues.

Adverse event reporting obligations for EUA-qualified devices

Although FDA issues EUAs on a case-by-case basis, these authorizations generally include similar adverse event reporting requirements. Manufacturers should refer to the Conditions of Authorization sections of their EUA documents for specific requirements.

Typically, manufacturers must comply with reporting requirements established in 21 CFR Part 803, which also apply to devices cleared or approved for US market access via standard registration routes.

Report submission guidelines and timeframes

As is the case for conventionally FDA-cleared or approved devices, adverse event reports for EUA-designated devices should be submitted electronically and in accordance with the agency’s guidance on electronic medical device reporting.

Manufacturers have 30 calendar days after first receiving information on adverse events to submit reports to FDA. For adverse events requiring intervention or remedial action to address a risk of harm to public health, manufacturers have five calendar days to submit reports.

Proper use of medical device product codes

The FDA Q&A resource emphasizes the need for manufacturers to include accurate device product codes in their adverse event reports to ensure timely corrective actions and reduce the need for follow-up inquiries from the regulator.

FDA’s guidelines for adverse event reporting come as many EUA-designated devices including respirators, IVD test kits and personal protective equipment (PPE) have been on the US market for several weeks.

Additional US FDA and COVID-19 regulatory resources:

  • COVID-19 regulatory news and analysis resource center
  • US FDA Emergency Use Authorization (EUA) pathway for medical devices and IVDs
  • Webinar: US FDA’s EUA process

Author

  • Stewart Eisenhart

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