FDA Draft Guidance Suggests Streamlined Submission for Migrating IVDs | GenomeWeb
NEW YORK (GenomeWeb News) — The US Food and Drug Administration has just released a draft guidance covering submission regulations for diagnostics developers seeking approval for Class III in vitro diagnostic devices.
The guidance proposes a set of updates that FDA believes would create a less burdensome regulatory path to approval for a previously approved or licensed assay that is being migrated for use with another system for which it has not been approved.

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