The FDA issued a document reporting examples of real world evidence (RWE) application to support marketing applications for medical devices.
The document includes examples of RWE in several submission types: premarket notification 510(k) , De Novo, humanitarian device exemption (HDE), premarket approval (PMA) and more.
Some of the examples applications are based on real-world data collection from national registries; several others are extracted from international and sponsor registries, or a combination of registries and other sources.
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For more details, please see the document from the FDA.
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Thank you for the update! Great to see a greater focus on RWE