Home 5 Articles 5 Agency Temporarily Allows Modifications of Influenza and RSV Tests Without Premarket Notification

Agency Temporarily Allows Modifications of Influenza and RSV Tests Without Premarket Notification

by | Nov 5, 2020

On Oct. 13, the FDA issued new guidance on molecular diagnostic tests for influenza and respiratory syncytial virus (RSV). The upshot of the guidance is to temporarily allow makers of flu and RSV tests that the agency has already cleared to make certain modifications to those products without submitting 510(k) premarket notification in the interest […]

On Oct. 13, the FDA issued new guidance on molecular diagnostic tests for influenza and respiratory syncytial virus (RSV). The upshot of the guidance is to temporarily allow makers of flu and RSV tests that the agency has already cleared to make certain modifications to those products without submitting 510(k) premarket notification in the interest […]

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