The Food and Drug Administration (FDA) says in a Sept. 7 guidance document that it’s offering templates for diagnostics developers to use as they seek Emergency Use Authorization (EUA) from the U.S. agency for monkeypox diagnostic tests.
The templates, which offer information and recommendations, “reflect FDA’s current thinking on validation recommendations for monkeypox tests, and the data and information that developers should submit to facilitate the EUA process,” the agency’s guidance says, noting that developers are welcome to use “alternative approaches.”
Developers that want to take a different tack “should consider seeking FDA’s feedback or recommendations to help them through the EUA process,” the agency says.
Health and Human Services Secretary Xavier Becerra declared a public health emergency in the U.S. on Aug. 4, and on Sept. 7 he said the risk was great enough to warrant the issuance of EUAs for diagnostics to detect monkeypox.
While the Centers for Disease Control and Prevention (CDC) has already developed an FDA-cleared monkeypox diagnostic, the FDA in its guidance says the U.S. government “believes there are additional, critical needs for monkeypox tests at this stage of the outbreak.”
The guidance reminds test developers granted an EUA by the FDA that they must comply with Medical Device Reporting (MDR) rules for adverse events.
FDA Will Prioritize EUA Review
The FDA’s new guidance further says the agency will send to the front of the line EUA requests from “experienced developers” for high-throughput diagnostics, tests for use in the home, and “rapid” diagnostics.
Developers interested in requesting an EUA for a monkeypox test are being urged to send preliminary information to the FDA, including:
- Description of the test technology;
- Manufacturing capacity, including ramp-up time frames;
- Test throughput;
- Expected timeline for development, validation and submission of an EUA request; and
- Any available validation data, including data supporting the validity of testing any non-lesion-based sample types, if used.
This info should be sent to MPXDx@fda.hha.gov with the header: “Diagnostic Test for Monkeypox – Intent to Submit EUA Request – Test Summary Information.”
“After an EUA request has been submitted, FDA intends to notify test developers by email if FDA authorizes a test or declines to review, declines to issue, or otherwise decides not to authorize a test for any reason,” the agency’s guidance doc says.
If you’re a diagnostics developer and you’re considering submitting an EUA to the FDA, have a partner by your side that knows all about them. MEDIcept has helped many developers with the agency’s Emergency Use Authorization process during the COVID-19 public health emergency – and we can do the same for you. Learn more by visiting www.medicept.com or emailing firstname.lastname@example.org.
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For additional information, please contact Susan Reilly at SReilly@MEDIcept.com.