Act before FDA deadline on October 13
FDA EUA Assistance for Monkeypox Tests
The US Department of Health and Human Services (HHS) declared Monkeypox a public health emergency on August 9, 2022 , allowing the US FDA to grant Emergency Use Authorization (EUA) to IVD manufacturers developing monkeypox virus tests. FDA has issued an EUA guidance for monkeypox and is prioritizing the review of applications from experienced manufacturers with high manufacturing capacity who are developing:
- High-throughput monkeypox tests
- Monkeypox tests with home specimen collection
- Rapid diagnostic monkeypox tests, either molecular (ex. RT-PCR) or antigen
TE’s IVD Solutions Team has helped numerous COVID-19 test manufacturers meet FDA EUA requirements and our clinical and regulatory teams are ready to assist you in obtaining monkeypox EUA as quickly as possible. Time is of the essence as you must notify FDA of your intent to file an EUA no later than October 13, 2022.
Proven Expertise, From Concept to Market
How TE can help you get monkeypox virus test EUA from FDA
A key FDA requirement for granting a monkeypox Emergency Use Authorization is the requirement to conduct a clinical study with at least 30 positive and 30 negative samples from patients suspected of carrying the monkeypox virus. Antigen test developers must use actual clinical samples for this testing. With more than 125 clinical sites around the United States, TE can quickly execute a clinical study of your assay and demonstrate compliance with FDA sensitivity, specificity, and reactivity requirements for monkeypox tests. Our IVD Solutions team can:
- Advise you on or create the documents needed to file a pre-EUA with FDA, or submit the notification of your intent to submit an EUA
- Assist with necessary monkeypox assay validation
- Execute clinical performance studies
- Conduct usability studies
- Document how your test meets FDA sensitivity, specificity, and reactivity requirements
- Review labeling, claims and promotional materials to ensure compliance with FDA regulations
- Create and submit the EUA package
