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Home 5 Articles 5 FDA Re-Opens Door to Pre-Submission Requests for Non-COVID-19 IVD Tests

FDA Re-Opens Door to Pre-Submission Requests for Non-COVID-19 IVD Tests

by | Jun 15, 2022 | Articles, Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies, FDA-dtet

The move comes shortly after the FDA said it was going to decline some pre-submission requests to focus on pandemic-related diagnostics.

A female lab worker places a sample into a centrifuge in the lab in this stock photo
The FDA will once more accept all non-COVID-19 pre-submissions, but says it will likely review these submissions “under an extended timeline,” for now.

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