How to Obtain FDA Emergency Use Authorization (EUA) for a Monkeypox Test
The US Department of Health and Human Services (HHS) declared the monkeypox virus a public health emergency in early August 2022 . Soon thereafter FDA issued an Emergency Use Authorization (EUA) for monkeypox diagnostic tests followed by a detailed guidance document.
In simple terms, Emergency Use Authorization temporarily allows an IVD manufacturer or CLIA-certified lab to market a monkeypox test without the typical 510(k) clearance or PMA approval normally required to place a product on the market.
Applying lessons learned during the early days of COVID, FDA is taking a more orderly approach to issuing EUAs for monkeypox tests while emphasizing the urgency of getting it done quickly. The agency has set forth some specific criteria for issuance of an EUA as outlined below.
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NOTE: The FDA deadline to submit your intent to file a monkeypox test EUA is October 13. Act now!
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Who qualifies for an FDA EUA for monkeypox testing?
Just because you apply for EUA for your monkeypox test does not mean FDA will grant one, and FDA makes this very clear on page 7 of the guidance document. FDA is prioritizing the following in choosing who gets reviewed for an Emergency Use Authorization.
1. Experienced developers
• Prior success obtaining an EUA
• High manufacturing capacity
• Have current FDA approval or clearance for a diagnostic test
• Have similar experience and have no compliance issues with FDA
2. High throughput diagnostic tests and rapid tests
• Molecular or antigen tests that can produce results in less than 30 minutes
• Rapid tests
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TE has helped several IVD manufacturers obtain an FDA EUA for COVID tests and we can help you do the same for monkeypox. Find out how.
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Proven Expertise, From Concept to Market
Required information to submit to FDA
If you intend to submit a request for Emergency Use Authorization for your monkeypox PCR or antigen test, you must email (yes, email) the following information to FDA before October 13, 2022. FDA may choose to change this deadline.
- Description of the technology used for your monkeypox test
- Your expected timeline for development, validation, and EUA submission
- Any available validation data
- Throughput capacity of your test
- Overview of your manufacturing capacity including how long it will take you to ramp up production
The FDA will reply to developers who submit a request “on a rolling basis” at which time they will inform you whether they are authorizing a test or declining your request. That should happen pretty quickly since the FDA is keen to get viable monkeypox tests get to market fast.
CLIA certified labs
FDA has also indicated that it will consider for EUA monkey pox tests developed and performed in CLIA-certified laboratories if the test uses molecular PCR technology and uses lesion swabs to collect specimens. While FDA is not requiring EUA for lab developed tests at this time, labs still need to notify the FDA within specific timeframes.
If a “high-complexity” CLIA-certified lab decides to modify a cleared 510(k) or authorized monkeypox molecular diagnostic test it can do so if:
- Indications for use are not changed
- Analyte specific reagents are not changed
- Test has been validated
- Modifications don't adversely affect test performance
- Lab submits a notification of validation to the FDA
These general conditions also apply to commercial manufacturers modifying their own monkeypox molecular diagnostic test.
Act quickly or miss an opportunity
Manufacturers are labs that have an effective monkeypox test should take advantage of this opportunity not only because of the positive impact it can have on correctly diagnosing this virus in patients, but for the business opportunity it presents as well. The TE IVD Solutions Team has helped numerous IVD manufacturers obtain EUAs for COVID, steering them through the process of initial submission and additional clinical studies needed for eventual regulatory submission. We can help you do the same for monkeypox test but it’s essential that you act quickly.
Contact our team today to get started.
