Shifting Seamlessly From EUA to 510(k) for COVID-19 Assays

COVID-19 diagnostics marketed under Emergency Use Authorization (EUA) will eventually have to comply with U.S. FDA 510(k) requirements to remain on the market. Precision for Medicine experts are here to guide you through the process for clearance.

Shifting Seamlessly From EUA to 510(k) for COVID-19 Assays

Regulatory, Clinical and Quality Steps Required to Move from EUA to 510(k) approval.

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

100+

IVD pre-submissions, preclinical/ clinical trial designs and executions

250+

Marketing clearances and approvals for IVD submissions

100+

Companion diagnostics regulatory filings in countries around the globe

Market Access and Commercialization Strategy & Support Experience

PFM_500k_Landing_Page_Covid_Assay_Dollar_Icon
100+ successful diagnostics market access, strategy, and tactical project completions
PFM_500k_Landing_Page_Covid_Assay_World_Icon
Global experience in 15+ markets on 3 continents