FDA Finalizes De Novo Process, Updates Related Guidance Docs
Executive Summary
The pathway is used to clear class I and II products that don’t have a predicate device, including many innovative technologies. The original draft rule came out in 2018.
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Global Medtech Guidance Tracker: September 2021
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 50 documents have been posted on the tracker since its last update.