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FDA Releases Six More De Novo Summaries

 
• By Elizabeth Orr

The US FDA released six more device classifications in early September, including products from Edwards, Interscope, and Baxter Healthcare.

Sorting colored pawns into categories.
• Source: Shutterstock

The US Food and Drug Administration has announced class II status for an additional six device types that initially reached market via the de novo pathway, bringing the total number of newly classified devices to 15 since mid-August.

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