Latest announcement by the FDA

We are delighted for the move forward by the FDA. While the EUA is still an on-going process, the FDA is ready for highly anticipated 510(k) approval. We are committed for both paths as outlined before. However, a traditional approval is going to be more appreciated by the market (clients) as it will only allow MDSAP approved manufacturers and hence ensure the highest quality.

MedMira's factory holds the required FDA Establishment License and is MDSAP certified since 2021.

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-updates-covid-19-test-policy-encourages-developers-seek-traditional?utm_medium=email&utm_source=govdelivery