Shifting Seamlessly From EUA to 510(k) for COVID-19 Assays
Regulatory, Clinical and Quality Steps Required to Move From EUA to 510(k) Clearance
Since the emergence of the COVID-19 pandemic, an intense research effort has been focused on swiftly bringing diagnostic tests to market under EUA. Now, with the availability of three COVID-19 vaccines, we can look forward to a steady increase in population immunity. Many project the COVID-19 Public Health Emergency to end in 2021. By that time, we expect diagnostic EUAs to start transitioning to expiration as the FDA authorizes the ﬁrst de novo COVID-19 tests, providing predicates for 510(k) clearance to support continued marketing of others.
With hundreds of Emergency Use – authorized COVID-19 assays potentially transitioning to 510(k) clearance in a short period, you should plan now for the necessary validation studies and regulatory findings.
Precision for Medicine supports the efforts of companies developing COVID-19 diagnostics with:
- COVID-19 biospecimens sourced from our clinics and biobank
- Deep practical experience with COVID-19 EUAs, and 510(k) clearances for diagnostic tests
- Broad expertise in evolving US and EU diagnostic regulations
- Comprehensive lab support for immune monitoring, antibody characterization, and related research
Precision’s Unmatched Experience in Diagnostic Development Takes Your COVID-19 Product From Bench to Bedside
Speak With an Expert About Your EUA Transition
With hundreds of Emergency Use– authorized COVID-19 assays potentially transitioning to 510(k) clearance in a short period, you should plan now for the necessary validation studies and regulatory filings.
Regulatory Strategy & Submissions Experience
IVD pre-submissions, preclinical/ clinical trial designs and executions
Marketing clearances and approvals for IVD submissions
Companion diagnostics regulatory filings in countries around the globe